Oncology Pipeline

For more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world. In 2019 Lilly created Loxo Oncology at Lilly, with the goal of rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating new medicines that work in early clinical development and will matter to patients.

Phase 2

NCT03086369

Pancreatic Cancer

PDGFRα Antibody


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*

NCT03086369
Key Inclusion Criteria
  • Adenocarcinoma of the exocrine pancreas that is metastatic (stage IV) and not amenable to resection with curative intent
  • Clinically significant or symptomatic amounts of ascites should be drained prior to day 1
  • No prior line of systemic therapy for metastatic disease
  • 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 pretreatment biopsy
  • Measurable or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Discontinued all previous treatments for cancer ≥4 weeks prior to study entry
  • Adequate organ function
  • Life expectancy of at least 3 months
  • Must be at least 18 years old
Key Exclusion Criteria
  • Serious concomitant systemic disorder
  • First-line treatment for metastatic pancreatic cancer
  • Prior treatment with nab-paclitaxel
  • Known central nervous system malignancy or metastasis
  • Current hematologic malignancies
  • Currently enrolled in or participated in another clinical trial within the last 30 days
  • Pregnant or breastfeeding
  • Endocrine pancreatic tumors or ampullary cancer
  • Known additional malignancy that has progressed or required active treatment within 1 year of study entry
  • Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations
*
This clinical trial is being conducted globally.
Olaratumab is administered intravenously (IV) on days 1, 8, and 15 or days 1 and 15 of a 28-day cycle.
Nab-paclitaxel is administered IV on days 1, 8, and 15 of a 28-day cycle.
§
Gemcitabine is administered IV on days 1, 8, and 15 of a 28-day cycle.
Placebo is administered IV on days 1, 8, and 15 or days 1 and 15 of a 28-day cycle.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.