Description:
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.
Title
- Brief Title: A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
- Official Title: A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
Clinical Trial IDs
- ORG STUDY ID:
15844
- SECONDARY ID:
I5B-MC-JGDP
- SECONDARY ID:
2016-001099-31
- NCT ID:
NCT03086369
Conditions
- Metastatic Pancreatic Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Olaratumab | LY3012207 | Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion) |
| Nab-paclitaxel | | Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion) |
| Gemcitabine | | Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion) |
| Placebo | | Placebo + Nab-paclitaxel + Gemcitabine |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Olaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation) | Experimental | (Open Label) Olaratumab, nab-paclitaxel and gemcitabine given intravenously (IV). | - Olaratumab
- Nab-paclitaxel
- Gemcitabine
|
| Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion) | Experimental | (Open Label) Olaratumab, nab-paclitaxel and gemcitabine given IV. | - Olaratumab
- Nab-paclitaxel
- Gemcitabine
|
| Olaratumab + Nab-paclitaxel + Gemcitabine (Treatment) | Experimental | (Double Blind) Olaratumab, nab-paclitaxel and gemcitabine given IV. | - Olaratumab
- Nab-paclitaxel
- Gemcitabine
|
| Placebo + Nab-paclitaxel + Gemcitabine | Placebo Comparator | (Double Blind) Placebo, nab-paclitaxel and gemcitabine given IV. | - Nab-paclitaxel
- Gemcitabine
- Placebo
|
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that
is metastatic (Stage IV) and not amenable to resection with curative intent.
- If present, clinically significant or symptomatic amounts of ascites should be drained
prior to Day 1.
- Have had no prior systemic treatment for metastatic disease. Prior adjuvant or
neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed
if completed ≥3 months prior to enrollment and no lingering toxicities are present.
- Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
- Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
- Measurable or nonmeasurable but evaluable disease as defined by the Response
Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Discontinued all previous treatments for cancer ≥4 weeks prior.
- Adequate organ function.
- Life expectancy of at least 3 months.
Exclusion Criteria:
- Serious concomitant systemic disorder.
- Have received first line treatment for metastatic pancreatic cancer.
- Received prior treatment with nab-paclitaxel.
- Have known central nervous system malignancy or metastasis.
- Current hematologic malignancies.
- Participated within the last 30 days in a clinical trial involving an investigational
product.
- Women with a positive pregnancy test or lactating.
- Have endocrine pancreatic tumors or ampullary cancer.
- Currently enrolled in another clinical trial.
- Have a known additional malignancy that is progressing or required active treatment
within the past 1 year.
- Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug
formulations.
- Are taking certain anti-coagulant medications such as warfarin and are unable to be
switched to other similar medicines.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of Participants with Dose Limiting Toxicities (DLTs) Phase 1b |
| Time Frame: | Cycle 1 (28 Days) |
| Safety Issue: | |
| Description: | Number of participants with DLTs phase 1b |
Secondary Outcome Measures
| Measure: | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab |
| Time Frame: | Baseline through End of Study (Approximately 9 Months) |
| Safety Issue: | |
| Description: | PK: Cmin of olaratumab |
| Measure: | Number of Participants with Anti-Olaratumab Antibodies |
| Time Frame: | Baseline through End of Study (Approximately 9 Months) |
| Safety Issue: | |
| Description: | Number of participants with anti-olaratumab antibodies |
| Measure: | OS Phase 1b |
| Time Frame: | Baseline to Date of Death from Any Cause (Approximately 9 Months) |
| Safety Issue: | |
| Description: | OS phase 1b |
| Measure: | Progression-Free Survival (PFS) |
| Time Frame: | Baseline to Disease Progression or Death (Approximately 6 Months) |
| Safety Issue: | |
| Description: | PFS |
| Measure: | Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR) |
| Time Frame: | Baseline through Disease Progression or Death (Approximately 6 Months) |
| Safety Issue: | |
| Description: | ORR: Percentage of participants who achieve CR or PR |
| Measure: | Duration of Response (DoR) |
| Time Frame: | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 5.5 Months) |
| Safety Issue: | |
| Description: | DoR |
| Measure: | Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score" |
| Time Frame: | Baseline through Follow-up (Approximately 9 Months) |
| Safety Issue: | |
| Description: | Time to first worsening of the mBPI-sf "worst pain score" |
| Measure: | Time to Sustained Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scale Scores |
| Time Frame: | Baseline through Follow-up (Approximately 9 Months) |
| Safety Issue: | |
| Description: | Time to sustained worsening of symptom burden on the EORTC QLQ-C30 scale scores |
| Measure: | Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L) |
| Time Frame: | Baseline through Follow-up (Approximately 9 Months) |
| Safety Issue: | |
| Description: | Health status on the EQ-5D-5L |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Eli Lilly and Company |
Last Updated
July 7, 2021
