A Phase 1/2 interventional study of Olaratumab and Nab-paclitaxel in Metastatic Pancreatic Cancer, sponsored by Eli Lilly and Company. Completed at 34 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-28.
Sponsored by Eli Lilly and Company · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 184 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m\^2) and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Drug: Olaratumab · Drug: Nab-paclitaxel · Drug: Gemcitabine
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Drug: Olaratumab · Drug: Nab-paclitaxel · Drug: Gemcitabine
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Drug: Olaratumab · Drug: Nab-paclitaxel · Drug: Gemcitabine
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Drug: Olaratumab · Drug: Nab-paclitaxel · Drug: Gemcitabine
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\^2 and gemcitabine 1000 mg/m\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Drug: Nab-paclitaxel · Drug: Gemcitabine · Drug: Placebo
Administered IV
Also known as: LY3012207
Administered IV
Administered IV
Administered IV
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03: 1. Any febrile neutropenia 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage 3. Grade 4 neutropenia lasting 7 days or longer 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc. 5. Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
Time frame: Cycle 1 (Up to 28 days)
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Time frame: Baseline to Date of Death from Any Cause (Up To 29 Months)
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
PK: Cmin of olaratumab
Time frame: Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Time frame: Baseline through Follow-up (Up To 29 Months)
Phase 1b: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Time frame: Baseline to Date of Death from Any Cause (Approximately 9 Months)
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 \[RECIST v.1.1\]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
Time frame: Baseline to Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Time frame: Baseline through Disease Progression or Death (Up To 26 Months)
Phase 1b/2: Duration of Response (DoR)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
Time frame: From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Time frame: Baseline through Follow-up (Up To 21 Months)
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Time frame: Baseline through Follow-up (Up To 21 Months)
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Time frame: Cycle 1 Day 1, Cycle 7 Day 1
| Milestone | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|---|---|
| Started | 3 | 7 | 12 | 82 | 80 |
| Received at least 1 dose of study drug | 3 | 7 | 12 | 81 | 78 |
| Completed | 2 | 7 | 12 | 73 | 73 |
| Not completed | 1 | 0 | 0 | 9 | 7 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 2 | 1 |
| Withdrew: Physician decision | 0 | 0 | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 5 | 3 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 1 | 1 |
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03: 1. Any febrile neutropenia 2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage 3. Grade 4 neutropenia lasting 7 days or longer 4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc. 5. Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
| Participants | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 0 | 0 |
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
| Months | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|
| Phase 2: Overall Survival (OS) | 9.10 (7.49 to 14.09) | 10.81 (8.51 to 14.75) |
PK: Cmin of olaratumab
| micrograms per milliliter (μg/mL) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|---|
| Cycle 1 (Day 1) | 128 ± 36 | 86.3 ± 90 | 87.8 ± 91 | 112 ± 40 |
| Cycle 1 (Day 15) | 78.7 ± 42 | 172 ± 76 | 101 ± 36 | 94.7 ± 62 |
| Cycle 3 (Day 1) | 204 ± 13 | NA ± NA | 173 ± 33 | 147 ± 38 |
| Cycle 3 (Day 15) | 159 ± 17 | NA ± NA | 101 ± 37 | 106 ± 68 |
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
| Participants | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine |
|---|---|
| Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies | 0 |
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
No measurements were reported for this outcome.
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 \[RECIST v.1.1\]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
| Months | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|
| Phase 2: Progression-Free Survival (PFS) | 5.55 (4.14 to 7.0) | 6.41 (5.42 to 7.98) |
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
| Percentage of participants | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|---|---|
| Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | 33.3 | 14.3 | 0 | 30.5 | 33.8 |
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
| Months | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|---|---|
| Phase 1b/2: Duration of Response (DoR) | NA (NA to NA) | NA (NA to NA) | — | 5.55 (2.63 to 9.23) | 5.55 (3.84 to 7.26) |
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
| Months | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|
| Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" | 14.13 (5.19 to NA) | 6.11 (2.04 to 9.95) |
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
| Months | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|
| Appetite loss | NA (2.79 to NA) | 2.86 (1.94 to NA) |
| Constipation | NA (2.76 to NA) | NA (1.94 to NA) |
| Diarrhoea | 2.79 (1.87 to NA) | 1.97 (1.91 to NA) |
| Dyspnoea | 2.79 (2.10 to NA) | 3.12 (2.07 to NA) |
| Fatigue | 1.87 (1.05 to 2.33) | 1.87 (1.12 to 2.07) |
| Financial difficulties | NA (2.37 to NA) | NA (2.79 to NA) |
| Insomnia | 3.19 (2.10 to NA) | NA (2.83 to NA) |
| Nausea and vomiting | 3.19 (2.10 to NA) | 2.86 (1.97 to NA) |
| Pain | NA (2.76 to NA) | 3.25 (2.04 to NA) |
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
| score on a scale | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|
| Index Value [Cycle 1 (Day1)] | 0.8 ± 0.2 | 0.8 ± 0.2 |
| Index Value [Cycle 7 (Day1)] | 0.8 ± 0.1 | 0.8 ± 0.2 |
| VAS Score [Cycle 1 (Day1)] | 70.1 ± 21.7 | 69.7 ± 20.4 |
| VAS Score [Cycle 7 (Day1)] | 71.7 ± 20.2 | 73.2 ± 22.5 |
Collected over Baseline to Follow-up (Up To 29 Months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 2/3 (66.7%) | 3/3 (100%) | 3/3 (100%) |
| Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 7/7 (100%) | 3/7 (42.9%) | 7/7 (100%) |
| Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 12/12 (100%) | 8/12 (66.7%) | 12/12 (100%) |
| Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 60/81 (74.1%) | 50/81 (61.7%) | 79/81 (97.5%) |
| Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 63/78 (80.8%) | 41/78 (52.6%) | 78/78 (100%) |
| Event | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|---|---|
| Pancreatic cystGastrointestinal disorders | 1/3 | 0/7 | 0/12 | 0/81 | 0/78 |
| PyrexiaGeneral disorders | 1/3 | 0/7 | 1/12 | 5/81 | 4/78 |
| Device related bacteraemiaInfections and infestations | 1/3 | 0/7 | 0/12 | 0/81 | 0/78 |
| Device related infectionInfections and infestations | 1/3 | 0/7 | 0/12 | 0/81 | 2/78 |
| Postoperative wound infectionInfections and infestations | 1/3 | 0/7 | 0/12 | 0/81 | 0/78 |
| Septic shockInfections and infestations | 1/3 | 0/7 | 0/12 | 2/81 | 2/78 |
| Wound infectionInfections and infestations | 1/3 | 0/7 | 0/12 | 0/81 | 0/78 |
| FallInjury, poisoning and procedural complications | 1/3 | 0/7 | 0/12 | 0/81 | 0/78 |
| Hip fractureInjury, poisoning and procedural complications | 1/3 | 0/7 | 0/12 | 0/81 | 0/78 |
| Confusional statePsychiatric disorders | 1/3 | 0/7 | 1/12 | 1/81 | 0/78 |
| Event | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine |
|---|---|---|---|---|---|
| FatigueGeneral disorders | 2/3 | 3/7 | 9/12 | 53/81 | 44/78 |
| AnaemiaBlood and lymphatic system disorders | 2/3 | 2/7 | 5/12 | 46/81 | 45/78 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/3 | 1/7 | 5/12 | 7/81 | 12/78 |
| ConstipationGastrointestinal disorders | 2/3 | 4/7 | 4/12 | 22/81 | 30/78 |
| DiarrhoeaGastrointestinal disorders | 2/3 | 1/7 | 7/12 | 40/81 | 30/78 |
| Oedema peripheralGeneral disorders | 2/3 | 0/7 | 5/12 | 25/81 | 28/78 |
| Neutrophil count decreasedInvestigations | 2/3 | 3/7 | 4/12 | 31/81 | 25/78 |
| Abdominal painGastrointestinal disorders | 0/3 | 1/7 | 6/12 | 15/81 | 16/78 |
| NauseaGastrointestinal disorders | 1/3 | 3/7 | 6/12 | 33/81 | 39/78 |
| Vulvovaginal pruritusReproductive system and breast disorders | 1/2 | 0/3 | 0/3 | 0/29 | 0/35 |
All participants in phase 1b/2.
| Age, Categorical(Participants) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 3 | 4 | 32 | 37 | 76 |
| >=65 years | 3 | 4 | 8 | 50 | 43 | 108 |
| Sex: Female, Male(Participants) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| Female | 2 | 3 | 3 | 29 | 35 | 72 |
| Male | 1 | 4 | 9 | 53 | 45 | 112 |
| Ethnicity (NIH/OMB)(Participants) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 7 | 8 | 16 |
| Not Hispanic or Latino | 3 | 7 | 11 | 74 | 70 | 165 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 0 | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 4 | 3 | 7 |
| White | 3 | 7 | 12 | 72 | 73 | 167 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 2 | 2 | 4 |
| Region of Enrollment(Participants) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | Total |
|---|---|---|---|---|---|---|
| United States | 1 | 5 | 7 | 76 | 73 | 162 |
| Germany | 1 | 1 | 5 | 3 | 3 | 13 |
| Spain | 1 | 1 | 0 | 3 | 4 | 9 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
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