A Phase 1 interventional study of Ferumoxytol and MM-398 in Solid Tumors, ER/PR Positive Breast Cancer and Triple Negative Breast Cancer, sponsored by Ipsen. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Ipsen · Phase 1, Interventional, and Other
This is a Phase I study to understand the biodistribution of MM-398 and to determine the feasibility of using Ferumoxytol as a tumor imaging agent.
This study is conducted over two phases.
Pilot Phase: This study will enroll approximately 12 patients, up to 20 in total in the Pilot Phase and 30 patients in the Expansion Phase. The first three patients that are enrolled in the Pilot Phase can have any solid tumor type; however subsequent patients must have Non-small cell lung cancer (NSCLC), Colorectal cancer (CRC), Triple negative breast cancer (TNBC), Estrogen Receptor/Progesterone Receptor (ER/PR) positive breast cancer, pancreatic cancer, ovarian cancer, gastric cancer, gastro-oesophageal junction adenocarcinoma or head and neck cancer. No more than three patients with ER/PR positive breast cancer can be enrolled in the Pilot Phase and similar restrictions may be placed on other tumor types to ensure a heterogeneous population.
Expansion Phase: The expansion will enroll patients with advanced metastatic breast cancer into three cohorts of 10 patients each depending on sub-type of breast cancer:
Cohort 1: ER and/or PR-positive breast cancer Cohort 2: TNBC Cohort 3: BC with active brain metastasis
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's enrollment of 45 is below the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.
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All subjects:
Pilot study only:
- CRC, TNBC, ER/PR Breast Cancer, NSCLC, Pancreatic Cancer, Ovarian Cancer, Gastric Cancer, Gastroesophageal Junction (GEJ) adenocarcinoma, Head and Neck Cancer
Expansion Phase Additional Criteria:
Expansion Phase Cohort 3 additional inclusion criteria:
Exclusion Criteria:
Ferumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 IV over 90 min on Days 1 and 15 of every 4 week cycle
Drug: Ferumoxytol · Drug: MM-398
Ferumoxytol 5 mg/kg IV at the rate of 1 mL/sec, given once on Day 1. MM-398 IV over 90 min dose 1 on Days 1 and 15 of every 4 week cycle Cohort 1: ER and/or PR-positive BC Cohort 2: TNBC Cohort 3: BC with active brain metastasis
Drug: Ferumoxytol · Drug: MM-398
Ferumoxytol 5 mg/kg IV as a single bolus injection, given once.
MM-398 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity
Pilot Phase: Tumour Levels of Irinotecan and SN-38 at Cycle 1 Day 4
Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal change on either the T2 or T1 sequences, based on FMX-MRI. The second core biopsy was taken from the region that showed the least signal change based on FMX-MRI, avoiding areas of necrosis.
Time frame: At Cycle 1 Day 4 in the Pilot phase.
Expansion Phase: Impact of the Quality of MRI Scan on Tumour Evaluation
Feasibility of FMX quantitation in tumour lesion was assessed through the acquisition of baseline (pre-FMX dose) and follow-up (post FMX dose) scans of sufficient quality to enable quantitative analysis to be performed. Quality was assessed by summarising scans as adequate for tumour evaluation or suboptimal but for which evaluation was completed for evaluation. Two FMX-MRI scans were taken on Day 1 (pre-FMX dosing) and on Day 2 (16-24 hours post dose) of the FMX phase. One MRI scan was also taken at 1-4 hours post FMX dose (Day 1 of FMX phase) and at 2 weeks post FMX dose (Day 15 of the MM-398 phase). It was possible for a subject to have 2 FMX-MRI scans for the same visit and timepoint corresponding to a scan target location. The number of MRI scan results that were assessed to be adequate or suboptimal at each timepoint are presented.
Time frame: Expansion phase Cycle 1: Pre FMX dose, 1-4 hours post FMX dose, 16-24 hours post FMX dose, 2 weeks Post FMX dose.
Expansion Phase: Best Overall Tumour Response (BOR) by Tumour FMX Uptake Classification at 16 - 24 Hours Post-FMX Dose
FMX tumour uptake was classified as 'low tumour uptake' or 'high tumour uptake', and was determined for 16 to 24-hours post-FMX dosing. The FMX uptake in a subject's lesions was classified using the median of the baseline-corrected FMX values at that timepoint across all subjects. The best radiological overall tumour response to MM-398 from the beginning to the end of the study was assessed using both the Investigator and imaging results per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Non-central nervous system \[CNS\] assessments; Cohorts 1, 2 and 3). Tumour response was classified as a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). BOR is presented by tumour uptake classification at 16-24 hours post-FMX dose by cohort for the non-CNS RECIST assessment.
Time frame: Expansion phase: C1D2 FMX phase, and every 8 weeks for RECIST assessments from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Median Progression-free Survival (PFS) (Non-CNS Assessment)
PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by RECIST per Investigator assessment or death due to any cause, whichever occurred first. The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on non-CNS assessment is presented.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Median PFS for Cohort 3 (CNS Assessment)
PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by modified RECIST (mRECIST) criteria (CNS disease; Cohort 3) per Investigator assessment or death due to any cause, whichever occurred first. The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on CNS mRECIST assessment is provided for Cohort 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: BOR (Non-CNS Assessment)
BOR was defined as the best response by RECIST version 1.1 (Non-CNS assessments) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery. Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: BOR for Cohort 3 (CNS Assessment)
BOR was defined as the best response by mRECIST criteria (CNS disease; Cohort 3) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery. Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for CNS assessments for Cohort 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Objective Response Rate (ORR) (Non-CNS Assessment)
The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: ORR for Cohort 3 (CNS Assessment)
The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for CNS assessments for Cohort 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Median Duration of Objective Response (DOR) (Non-CNS Assessment)
DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using RECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1-3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: Median DOR for Cohort 3 (CNS Assessment)
DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using mRECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for CNS assessments for Cohort 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Clinical Benefit Response (CBR) (Non-CNS Assessment)
CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for non-CNS assessments.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Expansion Phase: CBR for Cohort 3 (CNS Assessment)
CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for CNS assessment for Cohort 3.
Time frame: Baseline and every 8 weeks from C1D1 until disease progression, unacceptable toxicity or withdrawal of consent.
Pilot Phase + Expansion Phase: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) Related to MM-398
The number of subjects who experienced a TEAE reported to be related to MM-398 by the Investigator are presented for the Pilot and Expansion phases. An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing.
Time frame: From MM-398 treatment start up to 30 days after last dose.
Pilot Phase: Time to Reach Maximum Plasma Concentration of Irinotecan and SN-38 (Tmax)
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 salt-base equivalent \[SBE\]). The pharmacokinetic (PK) analysis was based on non-compartmental analysis. Any plasma concentrations below the lower limit of quantification (LLOQ) were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 micrograms per millilitre (mcg/mL), and for SN-38 the LLOQ for the Pilot phase was 0.441 nanograms per millilitre (ng/mL). The median tmax is presented for the Pilot phase.
Time frame: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.
Expansion Phase: Irinotecan and SN-38 Tmax
For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL and for SN-38 the LLOQ for the Expansion phase was 0.600 ng/mL. The median tmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
Time frame: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.
Pilot Phase: Maximum Observed Plasma Concentration of Irinotecan (Cmax)
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Pilot phase.
Time frame: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.
Pilot Phase: SN-38 Cmax
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean Cmax is presented for the Pilot phase.
Time frame: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.
Expansion Phase: Irinotecan Cmax
For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
Time frame: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.
Expansion Phase: SN-38 Cmax
For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean Cmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
Time frame: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.
Pilot Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) for Irinotecan
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Pilot phase.
Time frame: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.
Pilot Phase: SN-38 AUC(0-tlast)
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean AUC(0-tlast) is presented for the Pilot phase.
Time frame: Pilot phase: C1D1 pre-MM-398 infusion, end of infusion, post-infusion (2, 72, 168 hours); C1D15 pre-infusion; 30 days follow-up visit.
Expansion Phase: Irinotecan AUC(0-tlast)
For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
Time frame: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.
Expansion Phase: SN-38 AUC(0-tlast)
For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean AUC(0-tlast) is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
Time frame: Expansion phase: Cycles 1-3 pre-MM-398 infusion, end of infusion, post-infusion (2, 48,168 hours); D15 pre-infusion; 30 days follow-up visit.
Six study centres in the United States recruited subjects into this Phase 1, 2-phase, non-comparative, open-label study. Each phase consisted of 4 stages: screening, ferumoxytol (FMX) treatment, irinotecan liposome injection (MM-398) treatment and follow-up (30 days after last dose).
| Milestone | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 |
|---|---|---|
| Started | 15 | 30 |
| Received fmx | 15 | 30 |
| Received fmx and mm-398 | 13 | 29 |
| Completed | 9 | 18 |
| Not completed | 6 | 12 |
| Withdrew: Progressive disease | 2 | 1 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Physician decision | 0 | 3 |
| Withdrew: Clinical deterioration | 3 | 6 |
| Withdrew: Toxicity related diarrhoea + progression | 0 | 1 |
Two tumour biopsies were collected 72 hours after the first MM-398 IV infusion during Cycle 1 of the MM-398 Treatment phase of the Pilot phase for determination of tumour levels of irinotecan and SN-38 (an active metabolite). The lesions selected for biopsy were based on the results of the FMX-MRI obtained on Days 1, 2 and 4 of the FMX phase, and were collected from a previously non-biopsied lesion. The first core biopsy was taken in the region of the tumour that showed the greatest signal change on either the T2 or T1 sequences, based on FMX-MRI. The second core biopsy was taken from the region that showed the least signal change based on FMX-MRI, avoiding areas of necrosis.
| nanograms per gram (ng/g) | Pilot Phase: FMX Then MM-398 |
|---|---|
| Irinotecan | 4253 ± 3600 |
| SN-38 | 38.1 ± 91.5 |
Feasibility of FMX quantitation in tumour lesion was assessed through the acquisition of baseline (pre-FMX dose) and follow-up (post FMX dose) scans of sufficient quality to enable quantitative analysis to be performed. Quality was assessed by summarising scans as adequate for tumour evaluation or suboptimal but for which evaluation was completed for evaluation. Two FMX-MRI scans were taken on Day 1 (pre-FMX dosing) and on Day 2 (16-24 hours post dose) of the FMX phase. One MRI scan was also taken at 1-4 hours post FMX dose (Day 1 of FMX phase) and at 2 weeks post FMX dose (Day 15 of the MM-398 phase). It was possible for a subject to have 2 FMX-MRI scans for the same visit and timepoint corresponding to a scan target location. The number of MRI scan results that were assessed to be adequate or suboptimal at each timepoint are presented.
| examined scans | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|
| Pre-FMX Dose (1): adequate | 4 | 3 | 7 |
| Pre-FMX Dose (1): suboptimal | 3 | 2 | 4 |
| Pre-FMX Dose (2): adequate | 0 | 1 | — |
| Pre-FMX Dose (2): suboptimal | 1 | 1 | — |
| 1-4 hours Post FMX: adequate | 4 | 1 | 5 |
| 1-4 hours Post FMX: suboptimal | 2 | 1 | 2 |
| 16-24 hours Post FMX (1): adequate | 4 | 3 | 6 |
| 16-24 hours Post FMX (1): suboptimal | 3 | 2 | 4 |
| 16-24 hours Post FMX (2): adequate | 0 | — | — |
| 16-24 hours Post FMX (2): suboptimal | 1 | — | — |
| Post FMX Day 15: adequate | 0 | 2 | — |
| Post FMX Day 15: suboptimal | 1 | 1 | — |
FMX tumour uptake was classified as 'low tumour uptake' or 'high tumour uptake', and was determined for 16 to 24-hours post-FMX dosing. The FMX uptake in a subject's lesions was classified using the median of the baseline-corrected FMX values at that timepoint across all subjects. The best radiological overall tumour response to MM-398 from the beginning to the end of the study was assessed using both the Investigator and imaging results per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (Non-central nervous system \[CNS\] assessments; Cohorts 1, 2 and 3). Tumour response was classified as a Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD). BOR is presented by tumour uptake classification at 16-24 hours post-FMX dose by cohort for the non-CNS RECIST assessment.
| Participants | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|
| High tumour uptake and CR | 1 | 0 | 0 |
| High tumour uptake and PR | 1 | 3 | 0 |
| High tumour uptake and SD | 0 | 2 | 0 |
| High tumour uptake and Non-CR/Non-PD | 0 | 0 | 0 |
| High tumour uptake and PD | 2 | 0 | 0 |
| Low tumour uptake and CR | 1 | 0 | 1 |
| Low tumour uptake and PR | 1 | 0 | 2 |
| Low tumour uptake and SD | 1 | 0 | 2 |
| Low tumour uptake and Non-CR/Non-PD | 0 | 0 | 0 |
| Low tumour uptake and PD | 0 | 0 | 1 |
PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by RECIST per Investigator assessment or death due to any cause, whichever occurred first. The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on non-CNS assessment is presented.
| months | Pilot Phase: FMX Then MM-398 | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|---|
| Pilot Phase + Expansion Phase: Median Progression-free Survival (PFS) (Non-CNS Assessment) | 1.8 (1.0 to 3.6) | 1.9 (1.1 to 15.1) | 4.3 (1.0 to 9.4) | 3.2 (0.9 to 26.1) |
PFS was defined as the time in months from first dose of MM-398 to the date of radiologic disease progression by modified RECIST (mRECIST) criteria (CNS disease; Cohort 3) per Investigator assessment or death due to any cause, whichever occurred first. The date of progression is defined as the earliest date that an overall tumour response of PD or death was recorded. For subjects who did not have a qualifying progressive disease or death, the date of censoring for PFS was the date when the last valid tumour assessment determined a lack of progression. The PFS assessed by the Investigator was analysed using the Kaplan-Meier method, and the median PFS based on CNS mRECIST assessment is provided for Cohort 3.
| months | Expansion Phase: Cohort 3 |
|---|---|
| Expansion Phase: Median PFS for Cohort 3 (CNS Assessment) | 3.6 (0.9 to 9.6) |
BOR was defined as the best response by RECIST version 1.1 (Non-CNS assessments) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery. Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.
| Participants | Pilot Phase: FMX Then MM-398 | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|---|
| CR | 0 | 0 | 0 | 0 |
| PR | 1 | 4 | 3 | 3 |
| SD | 5 | 0 | 3 | 2 |
| Non-CR/Non-PD | 0 | 0 | 0 | 0 |
| PD | 5 | 5 | 2 | 3 |
| Not evaluable | 2 | 1 | 1 | 2 |
BOR was defined as the best response by mRECIST criteria (CNS disease; Cohort 3) criteria per Investigator assessment, recorded from the first dose of MM-398 until disease progression or the start of new anti-cancer therapy and/or surgery. Tumour response was classified as CR, PR, SD or PD. Classification of SD required at least 1 assessment of SD at least 4 weeks after starting treatment. Subjects were categorised as not evaluable if there was insufficient data for response classification. The BOR is presented for CNS assessments for Cohort 3.
| Participants | Expansion Phase: Cohort 3 |
|---|---|
| CR | 0 |
| PR | 3 |
| SD | 3 |
| Non-CR/Non-PD | 0 |
| PD | 2 |
| Not evaluable | 2 |
The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for non-CNS assessments for the Pilot phase and Cohorts 1 - 3.
| percentage of participants | Pilot Phase: FMX Then MM-398 | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|---|
| Pilot Phase + Expansion Phase: Objective Response Rate (ORR) (Non-CNS Assessment) | 7.7 (0.19 to 36.03) | 40.0 (12.16 to 73.76) | 33.3 (7.49 to 70.07) | 30.0 (6.67 to 65.25) |
The ORR was defined as the percentage of subjects with a BOR of either a CR or PR relative to the total number of evaluable subjects. Subjects with insufficient data for response classification were classified as non-responders for objective response. The ORR is presented for CNS assessments for Cohort 3.
| percentage of participants | Expansion Phase: Cohort 3 |
|---|---|
| Expansion Phase: ORR for Cohort 3 (CNS Assessment) | 30.0 (6.67 to 65.25) |
DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using RECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for non-CNS assessments for the Pilot phase and Cohorts 1-3.
| months | Pilot Phase: FMX Then MM-398 | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|---|
| Pilot Phase + Expansion Phase: Median Duration of Objective Response (DOR) (Non-CNS Assessment) | 3.84 (3.84 to 3.84) | 7.46 (6.4 to 13.0) | 5.62 (3.7 to 7.4) | 4.14 (0.0 to 22.2) |
DOR was defined as the time from first documentation of response (CR or PR whichever occurred first, based on Investigator assessment using mRECIST criteria) to the date of disease progression or to death due to any cause, whichever occurred first. DOR was computed for subjects who had CR or PR as the BOR. For subjects who did not have a qualifying progressive disease or death, the date of censoring was the date when the last valid tumour assessment determined a lack of progression. The median DOR is presented for CNS assessments for Cohort 3.
| months | Expansion Phase: Cohort 3 |
|---|---|
| Expansion Phase: Median DOR for Cohort 3 (CNS Assessment) | 1.84 (0.0 to 1.9) |
CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for non-CNS assessments.
| percentage of participants | Pilot Phase: FMX Then MM-398 | Expansion Phase: Cohort 1 | Expansion Phase: Cohort 2 | Expansion Phase: Cohort 3 |
|---|---|---|---|---|
| Pilot Phase + Expansion Phase: Clinical Benefit Response (CBR) (Non-CNS Assessment) | 15.4 (1.92 to 45.45) | 40.0 (12.16 to 73.76) | 33.3 (7.49 to 70.07) | 30.0 (6.67 to 65.25) |
CBR was defined as the percentage of subjects with a BOR characterised as a CR at any time, PR at any time, or SD ≥ 24 weeks relative to the total number of evaluable subjects. The CBR is presented for CNS assessment for Cohort 3.
| percentage of participants | Expansion Phase: Cohort 3 |
|---|---|
| Expansion Phase: CBR for Cohort 3 (CNS Assessment) | 50.0 (18.71 to 81.29) |
The number of subjects who experienced a TEAE reported to be related to MM-398 by the Investigator are presented for the Pilot and Expansion phases. An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing.
| participants | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 |
|---|---|---|
| Pilot Phase + Expansion Phase: Number of Subjects Who Experienced Treatment Emergent Adverse Events (TEAEs) Related to MM-398 | 13 | 28 |
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 salt-base equivalent \[SBE\]). The pharmacokinetic (PK) analysis was based on non-compartmental analysis. Any plasma concentrations below the lower limit of quantification (LLOQ) were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 micrograms per millilitre (mcg/mL), and for SN-38 the LLOQ for the Pilot phase was 0.441 nanograms per millilitre (ng/mL). The median tmax is presented for the Pilot phase.
| hours | Pilot Phase: FMX Then MM-398 |
|---|---|
| Irinotecan | 1.72 (1.52 to 3.20) |
| SN-38 | 3.20 (1.65 to 75.22) |
For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) and SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL and for SN-38 the LLOQ for the Expansion phase was 0.600 ng/mL. The median tmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
| hours | Expansion Phase: FMX Then MM-398 |
|---|---|
| Irinotecan: Cycle 1 40 mg/m^2 SBE | NA (3.88 to 3.88) |
| Irinotecan: Cycle 1 60 mg/m^2 SBE | 1.71 (1.52 to 3.67) |
| Irinotecan: Cycle 1 80 mg/m^2 SBE | 1.73 (1.63 to 1.80) |
| Irinotecan: Cycle 2 40 mg/m^2 SBE | NA (1.98 to 1.98) |
| Irinotecan: Cycle 2 60 mg/m^2 SBE | 3.03 (1.58 to 3.62) |
| Irinotecan: Cycle 2 80 mg/m^2 SBE | 2.12 (1.70 to 3.55) |
| Irinotecan: Cycle 3 40 mg/m^2 SBE | NA (1.68 to 2.50) |
| Irinotecan: Cycle 3 60 mg/m^2 SBE | 3.26 (1.63 to 48.33) |
| Irinotecan: Cycle 3 80 mg/m^2 SBE | 2.47 (1.50 to 6.92) |
| SN-38: Cycle 1 60 mg/m^2 SBE | 3.08 (1.57 to 40.82) |
| SN-38: Cycle 2 60 mg/m^2 SBE | 25.88 (3.08 to 67.42) |
| SN-38: Cycle 2 80 mg/m^2 SBE | NA (1.70 to 1.70) |
| SN-38: Cycle 3 60 mg/m^2 SBE | 31.29 (1.65 to 44.95) |
| SN-38: Cycle 3 80 mg/m^2 SBE | NA (3.27 to 3.27) |
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Pilot phase.
| mcg/mL | Pilot Phase: FMX Then MM-398 |
|---|---|
| Pilot Phase: Maximum Observed Plasma Concentration of Irinotecan (Cmax) | 39.0 (20.4 to 47.1) |
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean Cmax is presented for the Pilot phase.
| ng/mL | Pilot Phase: FMX Then MM-398 |
|---|---|
| Pilot Phase: SN-38 Cmax | 2.40 (1.52 to 3.62) |
For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean Cmax is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
| mcg/mL | Expansion Phase: FMX Then MM-398 |
|---|---|
| Cycle 1 40 mg/m^2 SBE | NA (21.7 to 21.7) |
| Cycle 1 60 mg/m^2 SBE | 28.1 (20.8 to 40.4) |
| Cycle 1 80 mg/m^2 SBE | 44.4 (34.2 to 56.4) |
| Cycle 2 40 mg/m^2 SBE | NA (22.1 to 22.1) |
| Cycle 2 60 mg/m^2 SBE | 30.4 (15.7 to 37.3) |
| Cycle 2 80 mg/m^2 SBE | 46.6 (34.2 to 55.8) |
| Cycle 3 40 mg/m^2 SBE | NA (18.3 to 19.9) |
| Cycle 3 60 mg/m^2 SBE | 30.3 (17.5 to 40.8) |
| Cycle 3 80 mg/m^2 SBE | 45.8 (38.6 to 51.5) |
For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean Cmax is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
| ng/mL | Expansion Phase: FMX Then MM-398 |
|---|---|
| Cycle 1 60 mg/m^2 SBE | 3.08 (2.01 to 5.23) |
| Cycle 2 60 mg/m^2 SBE | 3.63 (1.74 to 7.62) |
| Cycle 2 80 mg/m^2 SBE | NA (4.14 to 4.14) |
| Cycle 3 60 mg/m^2 SBE | 2.60 (1.03 to 3.55) |
| Cycle 3 80 mg/m^2 SBE | NA (3.08 to 3.08) |
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Pilot phase.
| mcg*hours/mL (mcg*h/mL) | Pilot Phase: FMX Then MM-398 |
|---|---|
| Pilot Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Last Quantifiable Concentration (AUC[0-tlast]) for Irinotecan | 1721 (293 to 3758) |
In Cycle 1 only of the Pilot phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma following a dose of 70 mg/m\^2 MM-398 FBE (80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Pilot phase was 0.441 ng/mL. The mean AUC(0-tlast) is presented for the Pilot phase.
| ng*h/mL | Pilot Phase: FMX Then MM-398 |
|---|---|
| Pilot Phase: SN-38 AUC(0-tlast) | 212 (89.1 to 380) |
For the Expansion phase, samples were collected to determine the levels of total irinotecan (liposomal and free drug) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for irinotecan was 0.140 mcg/mL. The mean AUC(0-tlast) is presented for the Expansion phase. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
| mcg*h/mL | Expansion Phase: FMX Then MM-398 |
|---|---|
| Cycle 1 40 mg/m^2 SBE | NA (976 to 976) |
| Cycle 1 60 mg/m^2 SBE | 1430 (230 to 3301) |
| Cycle 1 80 mg/m^2 SBE | 1530 (541 to 2273) |
| Cycle 2 40 mg/m^2 SBE | NA (1185 to 1185) |
| Cycle 2 60 mg/m^2 SBE | 1589 (204 to 2963) |
| Cycle 2 80 mg/m^2 SBE | 1788 (902 to 2266) |
| Cycle 3 40 mg/m^2 SBE | NA (426 to 969) |
| Cycle 3 60 mg/m^2 SBE | 1700 (325 to 3001) |
| Cycle 3 80 mg/m^2 SBE | NA (1345 to 2288) |
For the Expansion phase, samples were collected to determine the levels of SN-38 (metabolite) in plasma and data is presented for Cycles 1 to 3 by dose received for each cycle (depending on dose titration): 35 to 70 mg/m\^2 MM-398 FBE (40 to 80 mg/m\^2 MM-398 SBE). The PK analysis was based on non-compartmental analysis. Any plasma concentrations below the LLOQ were assigned as missing/zero in the data set according to predetermined rules. The LLOQ for SN-38 for the Expansion phase was 0.600 ng/mL. The mean AUC(0-tlast) is presented for dose levels in the Expansion phase for which data was collected. PK results for subjects in all cohorts of the Expansion Phase were combined for those on the same cycle and at the same dose. The total number of subjects evaluated in the PK set for the Expansion Phase was 21, with different numbers evaluated for each cycle/dose.
| ng*h/mL | Expansion Phase: FMX Then MM-398 |
|---|---|
| Cycle 1 60 mg/m^2 SBE | 237 (40.5 to 599) |
| Cycle 2 60 mg/m^2 SBE | NA (237 to 353) |
| Cycle 2 80 mg/m^2 SBE | NA (354 to 354) |
| Cycle 3 60 mg/m^2 SBE | 214 (146 to 295) |
| Cycle 3 80 mg/m^2 SBE | NA (119 to 119) |
Collected over TEAEs were collected from MM-398 treatment start to end of study (approximately 6 years). An AE was considered treatment emergent if it began on or after the first administration of MM-398, started prior to dosing with MM-398 and increased in severity or seriousness after dosing, or started prior to dosing of MM-398 but the causality changed to 'related' after dosing.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pilot Phase: FMX Then MM-398 | 2/15 (13.3%) | 4/13 (30.8%) | 13/13 (100%) |
| Expansion Phase: FMX Then MM-398 | 1/30 (3.3%) | 17/29 (58.6%) | 29/29 (100%) |
| Event | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/13 | 5/29 |
| Abdominal painGastrointestinal disorders | 2/13 | 1/29 |
| NauseaGastrointestinal disorders | 1/13 | 3/29 |
| AstheniaGeneral disorders | 0/13 | 3/29 |
| VomitingGastrointestinal disorders | 1/13 | 1/29 |
| ColitisGastrointestinal disorders | 1/13 | 0/29 |
| Metastases to meningesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/13 | 0/29 |
| PneumoniaInfections and infestations | 0/13 | 2/29 |
| Duodenal perforationGastrointestinal disorders | 0/13 | 1/29 |
| EnteritisGastrointestinal disorders | 0/13 | 1/29 |
| Event | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 9/13 | 25/29 |
| NauseaGastrointestinal disorders | 9/13 | 15/29 |
| HypokalaemiaMetabolism and nutrition disorders | 8/13 | 11/29 |
| FatigueGeneral disorders | 3/13 | 17/29 |
| VomitingGastrointestinal disorders | 7/13 | 11/29 |
| ConstipationGastrointestinal disorders | 5/13 | 5/29 |
| AnaemiaBlood and lymphatic system disorders | 5/13 | 7/29 |
| Decreased appetiteMetabolism and nutrition disorders | 3/13 | 9/29 |
| NeutropeniaBlood and lymphatic system disorders | 4/13 | 2/29 |
| Back painMusculoskeletal and connective tissue disorders | 1/13 | 7/29 |
Baseline characteristics are presented for the safety population which included all subjects who received at least 1 dose of FMX or MM-398.
| Age, Categorical(Participants) | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 25 | 34 |
| >=65 years | 6 | 5 | 11 |
| Sex: Female, Male(Participants) | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 | Total |
|---|---|---|---|
| Female | 11 | 30 | 41 |
| Male | 4 | 0 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 13 | 27 | 40 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Pilot Phase: FMX Then MM-398 | Expansion Phase: FMX Then MM-398 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 2 | 2 |
| White | 14 | 23 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
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The record gives a start of Nov 2012, a primary completion of Oct 2018 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2019, 1 year after primary completion.
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Studies of the drugs tested here: Ferrosoferric Oxide · Irinotecan sucrosofate
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