A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With 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.
- Metastatic Pancreatic Cancer
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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.
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
Olaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)
|(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given intravenously (IV).||
Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion)
|(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given IV.||
Olaratumab + Nab-paclitaxel + Gemcitabine (Treatment)
|(Double Blind) Olaratumab, nab-paclitaxel and gemcitabine given IV.||
Placebo + Nab-paclitaxel + Gemcitabine
|(Double Blind) Placebo, nab-paclitaxel and gemcitabine given IV.||
- Active, not recruiting
- Eli Lilly and Company