Trial · NCT03086369
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
NCT03086369, Phase 1, Phase 2, Completed, Eli Lilly and Company; results first posted 2022-01-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer. Trials, record NCT03086369. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03086369
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
- NCT number
- NCT03086369
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 184 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Olaratumab, Nab-paclitaxel, Gemcitabine, Placebo
- First posted
- 2017-03-22
- Last updated
- 2022-06-28
- Other registries' IDs
- eudract:2016-001099-31
- Results first posted
- 2022-01-11
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (Up to 28 days) | 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). |
| Primary | Phase 2: Overall Survival (OS) | Baseline to Date of Death from Any Cause (Up To 29 Months) | 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. |
| Secondary | Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | 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 | PK: Cmin of olaratumab |
| Secondary | Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies | Baseline through Follow-up (Up To 29 Months) | Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies |
| Secondary | Phase 1b: Overall Survival (OS) | Baseline to Date of Death from Any Cause (Approximately 9 Months) | 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. |
| Secondary | Phase 2: Progression-Free Survival (PFS) | Baseline to Disease Progression or Death (Up To 26 Months) | 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. |
| Secondary | Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline through Disease Progression or Death (Up To 26 Months) | 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. |
| Secondary | Phase 1b/2: Duration of Response (DoR) | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months) | 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. |
| Secondary | Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" | Baseline through Follow-up (Up To 21 Months) | 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. |
| Secondary | 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. | Baseline through Follow-up (Up To 21 Months) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (Up to 28 days) | All participants in phase 1b who received at least one dose of Olaratumab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2: Overall Survival (OS) | Baseline to Date of Death from Any Cause (Up To 29 Months) | All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=26, Placebo+Nab-paclitaxel+Gemcitabine=21. | Months | MEDIAN |
| SECONDARY | Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | 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 | All participants in phase 1b/2 who received at least one dose of Olaratumab and had evaluable PK data. | micrograms per milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies | Baseline through Follow-up (Up To 29 Months) | All randomized participants in phase 2 who received at least one dose of Olaratumab and had evaluable immunogenicity data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Phase 1b: Overall Survival (OS) | Baseline to Date of Death from Any Cause (Approximately 9 Months) | Phase 1b: Zero participants analysed as data was not collected. OS was not measured in phase 1b. | ||
| SECONDARY | Phase 2: Progression-Free Survival (PFS) | Baseline to Disease Progression or Death (Up To 26 Months) | All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=24, Placebo+Nab-paclitaxel+Gemcitabine=26. | Months | MEDIAN |
| SECONDARY | Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) | Baseline through Disease Progression or Death (Up To 26 Months) | All participants in phase 1b/2. | Percentage of participants | NUMBER |
| SECONDARY | Phase 1b/2: Duration of Response (DoR) | From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months) | All participants in phase 1b/2 who had CR or PR responses. For phase 1b cohort expansion arm, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed. | Months | MEDIAN |
| SECONDARY | Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) Worst Pain Score | Baseline through Follow-up (Up To 21 Months) | All randomized participants in phase 2 who had baseline and at least one post-baseline assessment. | Months | MEDIAN |
| SECONDARY | 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. | Baseline through Follow-up (Up To 21 Months) | All randomized participants in phase 2 who had baseline and at least one post-baseline assessment. | Months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group61
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 0 | Participants | ||
| Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs) | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 0 | Participants | ||
| Phase 2: Overall Survival (OS) | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 9.10 | 95% Confidence Interval 7.49 to 14.09 | Months | |
| Phase 2: Overall Survival (OS) | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 10.81 | 95% Confidence Interval 8.51 to 14.75 | Months | |
| Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Cycle 1 (Day 1) | 128 | Geometric Coefficient of Variation 36 | micrograms per milliliter (μg/mL) |
| Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Cycle 1 (Day 1) | 86.3 | Geometric Coefficient of Variation 90 | micrograms per milliliter (μg/mL) |
| Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | Cycle 1 (Day 1) | 87.8 | Geometric Coefficient of Variation 91 | micrograms per milliliter (μg/mL) |
| Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | Cycle 1 (Day 1) | 112 | Geometric Coefficient of Variation 40 | micrograms per milliliter (μg/mL) |
| Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | Cycle 1 (Day 15) | 78.7 | Geometric Coefficient of Variation 42 | micrograms per milliliter (μg/mL) |
1 to 10 of 61Source ClinicalTrials.gov
See all 61 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 3 | |
| Overall Study | STARTED | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 7 | |
| Overall Study | STARTED | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 12 | |
| Overall Study | STARTED | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 82 | |
| Overall Study | STARTED | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 80 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 3 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 7 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 12 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 81 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 78 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,285
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 2 | 3 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 2 | 7 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 5 | 12 | 9 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 46 | 81 | 186 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 45 | 78 | 165 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 0 | 3 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 0 | 7 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 1 | 12 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 1 | 81 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 2 | 78 | 2 |
1 to 10 of 1,285Source ClinicalTrials.gov
See all 1,285 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 2 | 3 |
| Total, all-cause mortality | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 7 | 7 |
| Total, all-cause mortality | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 12 | 12 |
| Total, all-cause mortality | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 60 | 81 |
| Total, all-cause mortality | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 63 | 78 |
| Total, other adverse events | Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine | 3 | 3 |
| Total, other adverse events | Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 7 | 7 |
| Total, other adverse events | Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine | 12 | 12 |
| Total, other adverse events | Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine | 79 | 81 |
| Total, other adverse events | Phase 2: Placebo + Nab-paclitaxel + Gemcitabine | 78 | 78 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
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