A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

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

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.

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.