A Phase 3 interventional study of MM-398 and 5 Fluorouracil in Metastatic Pancreatic Cancer, sponsored by Merrimack Pharmaceuticals. Completed at 79 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-17.
Sponsored by Merrimack Pharmaceuticals · Phase 3, Interventional, and Treatment
The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's enrollment of 417 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Merrimack Pharmaceuticals is the lead sponsor of 25 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
MM-398 120 mg/m2 Q3W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 120 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 100 mg/ m2 of irinotecan free base.
Drug: MM-398
5 Fluorouracil and Leucovorin IV
Drug: 5 Fluorouracil · Drug: Leucovorin
MM-398 80 mg/m2, 5-FU and Leucovorin Q2W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 80 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 70 mg/ m2 of irinotecan free base.
Drug: MM-398 · Drug: 5 Fluorouracil · Drug: Leucovorin
Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W
Also known as: PEP02
Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
Also known as: 5-FU
Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
Also known as: Folinic Acid
Overall Survival
Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
Time frame: From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.
Progression Free Survival
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
Time frame: Randomization until disease progression or death from any cause; Until the data cut off of 14 Feb 2014. The maximum time in follow up was 25 months.
Objective Response Rate
The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.
Time frame: Assessment every 6 weeks after initial response; Day 1 to data cut off of 14 Feb 2014; maximum time on study 25 months.
Time to Treatment Failure
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
Time frame: Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months
Percentage of Patients With Clinical Benefit Response
Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
Time frame: Randomization to treatment discontinuation.The maximum time in follow up was 25 months
Percentage of Patients With Tumor Marker (CA 19-9) Response
Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
EORTC-QLQ-C30
This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.
Time frame: Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
Pharmacokinetic Measurements of Total Irinotecan
Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.
Time frame: 6 weeks after first study drug administration
Patients were randomized over a period of 1.9 years starting from 2012-01-11 to 2013-09-11. The study was initially a two-arm study with MM-398 monotherapy and 5-FU/LV control (protocol version 1) . A third arm of MM-398+5-FU/LV was added later (protocol version 2).
| Milestone | MM-398 (Arm A) | 5-FU + Leucovorin (Arm B) | MM-398 + 5-FU + Leucovorin (Arm C) |
|---|---|---|---|
| Started | 151 | 149 | 117 |
| Treated population | 147 | 134 | 117 |
| Completed | 3 | 6 | 14 |
| Not completed | 148 | 143 | 103 |
| Withdrew: Lack of efficacy | 77 | 83 | 57 |
| Withdrew: Adverse event | 17 | 10 | 11 |
| Withdrew: Death | 9 | 5 | 2 |
| Withdrew: Physician decision | 7 | 5 | 4 |
| Withdrew: Withdrawal by subject | 17 | 20 | 14 |
| Withdrew: Clinical deterioration | 21 | 17 | 13 |
| Withdrew: Sponsor decision | 0 | 0 | 1 |
| Withdrew: Other | 0 | 3 | 1 |
Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
| months | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Overall Survival | 4.9 (4.23 to 5.62) | 4.2 (3.58 to 4.86) | 6.1 (4.76 to 8.87) | 4.2 (3.29 to 5.32) |
Progression-free survival was defined as the time from the date of randomization to the date of disease progression, or death (any cause) on or prior to the clinical cutoff date, whichever occurred earlier. Participants who did not have disease progression or had not died were censored at the date of the last tumor assessment. Patients with two or more consecutive missing response assessments prior to a visit with documented progression (or death) were censored at the last date of tumor assessment when the patient was documented to be progression free. PFS was summarized using Kaplan-Meier methods. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
| months | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Progression Free Survival | 2.7 (2.13 to 2.89) | 1.6 (1.41 to 1.84) | 3.1 (2.69 to 4.17) | 1.5 (1.41 to 1.84) |
The objective response rate was a secondary efficacy endpoint of the study and was defined by the percentage of patients in the study population with a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by the investigator. Best overall response was defined per RECIST (version 1.1) recorded from randomization until progression or end of study. RECIST (v 1.1) criteria does not require confirmation of response, but an additional, more stringent analysis was also conducted, with designation of CR (or PR) requiring confirmation of response at least 4 weeks following the initial assessment of CR (or PR). Stable disease (SD) required an assessment of SD at least 6 weeks after starting treatment. Subjects with insufficient data for response classification were classified as Not Evaluable for best overall response, and as a non-responder for objective response, in the ITT population. Treatment groups are as indicated for the primary outcome of OS.
| percentage with confirmed response | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Objective Response Rate | 3.31 (0.46 to 6.17) | 0.67 (0.0 to 1.98) | 7.69 (2.86 to 12.52) | 0.84 (0.0 to 2.48) |
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
| months | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Time to Treatment Failure | 1.7 (1.5 to 2.7) | 1.4 (1.3 to 1.4) | 2.3 (1.6 to 2.8) | 1.4 (1.3 to 1.4) |
Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
| percentage of participants with CBR | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Percentage of Patients With Clinical Benefit Response | 14 | 13 | 14 | 12 |
Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
| percent of participants with TMR | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Percentage of Patients With Tumor Marker (CA 19-9) Response | 23.6 | 11.4 | 28.9 | 8.6 |
This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.
| percent of patients in category | MM-398 Arm A (Mono Therapy Comparison) | 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 5-FU + Leucovorin (Combo Therapy Comparison) |
|---|---|---|---|---|
| Global Health Status: Improved | 10 | 11 | 17 | 12 |
| Global Health Status: Stable | 31 | 41 | 38 | 44 |
| Global Health Status: Worsened | 57 | 48 | 45 | 44 |
| Physical Functioning: Improved | 10 | 11 | 10 | 11 |
| Physical Functioning: Stable | 29 | 37 | 41 | 40 |
| Physical Functioning: Worsened | 61 | 52 | 49 | 49 |
| Role Functioning: Improved | 6 | 10 | 15 | 11 |
| Role Functioning: Stable | 29 | 39 | 32 | 37 |
| Role Functioning: Worsened | 66 | 52 | 52 | 53 |
| Emotional Functioning:Improved | 10 | 8 | 20 | 9 |
| Emotional Functioning:Stable | 32 | 59 | 46 | 58 |
| Emotional Functioning:Worsened | 56 | 33 | 34 | 33 |
| Cognitive Functioning:Improved | 12 | 6 | 11 | 7 |
| Cognitive Functioning:Stable | 32 | 42 | 48 | 44 |
| Cognitive Functioning:Worsened | 54 | 52 | 41 | 49 |
| Social Functioning:Improved | 11 | 11 | 13 | 11 |
| Social Functioning:Stable | 26 | 43 | 34 | 47 |
| Social Functioning:Worsened | 62 | 46 | 54 | 42 |
| Fatigue:Improved | 13 | 11 | 14 | 12 |
| Fatigue:Stable | 18 | 30 | 20 | 33 |
| Fatigue:Worsened | 69 | 59 | 66 | 54 |
| Nausea and Vomiting:Improved | 5 | 6 | 13 | 4 |
| Nausea and Vomiting:Stable | 37 | 42 | 32 | 46 |
| Nausea and Vomiting:Worsened | 58 | 52 | 55 | 51 |
| Pain:Improved | 20 | 10 | 27 | 11 |
| Pain:Stable | 30 | 37 | 34 | 40 |
| Pain:Worsened | 50 | 53 | 39 | 49 |
| Dyspnoea:Improved | 10 | 6 | 7 | 5 |
| Dyspnoea:Stable | 47 | 69 | 51 | 68 |
| Dyspnoea:Worsoned | 44 | 24 | 42 | 25 |
| Insomnia:Improved | 9 | 4 | 18 | 5 |
| Insomnia:Stable | 43 | 49 | 34 | 49 |
| Insomnia:Worsened | 48 | 47 | 48 | 46 |
| Appetite Loss:Improved | 9 | 6 | 11 | 5 |
| Appetite Loss:Stable | 38 | 42 | 45 | 46 |
| Appetite Loss:Worsened | 53 | 52 | 44 | 49 |
| Constipation:Improved | 13 | 4 | 13 | 4 |
| Constipation:Stable | 47 | 63 | 56 | 67 |
| Constipation:Worsened | 39 | 34 | 31 | 30 |
| Diarrhoea:Improved | 4 | 4 | 6 | 4 |
| Diarrhoea: Stable | 35 | 58 | 39 | 58 |
| Diarrhoea: Worsened | 59 | 39 | 55 | 39 |
| Financial Difficulties: Improved | 6 | 1 | 8 | 0 |
| Financial Difficulties: Stable | 51 | 67 | 51 | 74 |
| Financial Difficulties: Worsened | 42 | 31 | 41 | 26 |
Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.
| Total irinotecan = ug/L; SN38= ug/L | MM-398 Arm A (Mono Therapy Comparison) | MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison |
|---|---|---|
| Total Irinotecan-Cavg | 2550.00 ± 197.4 | 2120.00 ± 209.7 |
| Total Irinotecan-Cmax | 40550.00 ± 172.3 | 28460.00 ± 69.3 |
| Total SN38-Cavg | 0.82 ± 119.2 | 0.68 ± 132.7 |
| Total SN38-Cmax | 3.93 ± 119.6 | 2.58 ± 121.9 |
Collected over Study drug initiation through 30 days after the last dose of study drug or EOS, whichever is later; Up to 764 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MM-398 | — | 90/147 (61.2%) | 145/147 (98.6%) |
| 5 Fluorouracil and Leucovorin IV | — | 58/134 (43.3%) | 132/134 (98.5%) |
| MM-398, 5-FU and Leucovorin | — | 56/117 (47.9%) | 116/117 (99.1%) |
| Event | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 19/147 | 2/134 | 7/117 |
| VomitingGastrointestinal disorders | 14/147 | 2/134 | 11/117 |
| Abdominal PainGastrointestinal disorders | 6/147 | 6/134 | 5/117 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 6/147 | 1/134 | 2/117 |
| Decrease AppetiteMetabolism and nutrition disorders | 6/147 | 1/134 | 1/117 |
| NauseaGastrointestinal disorders | 5/147 | 1/134 | 4/117 |
| SepsisInfections and infestations | 3/147 | 1/134 | 4/117 |
| PyrexiaGeneral disorders | 5/147 | 2/134 | 3/117 |
| Abdominal Pain UpperGastrointestinal disorders | 4/147 | 1/134 | 1/117 |
| Device Related InfectionInfections and infestations | 1/147 | 0/134 | 3/117 |
| Event | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 103/147 | 35/134 | 116/117 |
| NauseaGastrointestinal disorders | 89/147 | 46/134 | 60/117 |
| VomitingGastrointestinal disorders | 80/147 | 35/134 | 61/117 |
| Decreased AppetiteMetabolism and nutrition disorders | 72/147 | 43/134 | 52/117 |
| FatigueGeneral disorders | 54/147 | 37/134 | 47/117 |
| AnaemiaBlood and lymphatic system disorders | 48/147 | 31/134 | 44/117 |
| Abdominal PainGastrointestinal disorders | 50/147 | 42/134 | 27/117 |
| ConstipationGastrointestinal disorders | 26/147 | 32/134 | 26/117 |
| AstheniaGastrointestinal disorders | 35/147 | 22/134 | 24/117 |
| PyrexiaGeneral disorders | 29/147 | 15/134 | 27/117 |
All randomized patients.
| Age, Categorical(Participants) | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 151 | 149 | 117 | 417 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin | Total |
|---|---|---|---|---|
| Mean | 63.6 ± 10.13 | 61.8 ± 9.65 | 63.2 ± 9.06 | 62.8 ± 9.68 |
| Sex: Female, Male(Participants) | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin | Total |
|---|---|---|---|---|
| Female | 64 | 68 | 48 | 180 |
| Male | 87 | 81 | 69 | 237 |
| RACE (NIH/OMB)(participants) | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 1 |
| Asian | 52 | 50 | 34 | 136 |
| Black or African American | 3 | 3 | 4 | 10 |
| White | 89 | 92 | 72 | 253 |
| other race | 6 | 4 | 7 | 17 |
| Karnofsky Performance Status (Baseline KPS)[1](participants) | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin | Total |
|---|---|---|---|---|
| 100% = normal, no complaints, no signs of disease | 22 | 22 | 18 | 62 |
| 90% = normal activity, few symptoms of disease | 64 | 54 | 51 | 169 |
| 80% = normal activity, some symptoms of disease | 50 | 61 | 38 | 149 |
| 70% = caring for self, unable to work | 15 | 11 | 7 | 33 |
| 60% [2] = needs help, can manage most tasks | 0 | 0 | 2 | 2 |
| 50%[2]= needs help often and medical care | 0 | 0 | 1 | 1 |
| Not recorded | 0 | 1 | 0 | 1 |
| Pancreatic Primary Tumor Location(participants) | MM-398 | 5 Fluorouracil and Leucovorin IV | MM-398, 5-FU and Leucovorin | Total |
|---|---|---|---|---|
| Head | 92 | 77 | 70 | 239 |
| Body | 16 | 26 | 12 | 54 |
| Tail | 24 | 24 | 14 | 62 |
| Multiple locations including head | 7 | 4 | 6 | 17 |
| Multiple locations not including head | 7 | 14 | 9 | 30 |
| Unknown = not specified | 5 | 4 | 6 | 15 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Irinotecan sucrosofate · Fluorouracil · Leucovorin