A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
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.
Condition
- Metastatic Pancreatic Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine |
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. |
|
Experimental Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + 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. |
|
Experimental Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + 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. |
|
Experimental Phase 2: Olaratumab + Nab-paclitaxel + 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. |
|
Placebo Comparator Phase 2: Placebo + Nab-paclitaxel + 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. |
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More Details
- Status
- Completed
- Sponsor
- Eli Lilly and Company