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 3

ANNOUNCE; NCT02451943

Sarcoma

PDGFRα Antibody


A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma*

NCT02451943
Key Inclusion Criteria
  • Locally advanced unresectable or metastatic disease not amenable to curative treatment with surgery or radiotherapy
  • 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
  • Completed all previous anticancer treatments ≥3 weeks prior to first dose of study drug
  • Availability of tumor tissue or willing to undergo a pretreatment biopsy of primary or metastatic tumor
  • Adequate hematologic, organ, and coagulation within 2 weeks prior to randomization
  • Left ventricular ejection fraction ≥50%
  • Life expectancy of ≥3 months
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization
  • Females of childbearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 3 months following the last dose of study drug
Key Exclusion Criteria
  • Gastrointestinal stromal tumor or Kaposi sarcoma
  • Active central nervous system or leptomeningeal metastasis (brain metastasis) at the time of randomization
  • Prior treatment with doxorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
  • Prior treatment with olaratumab
  • Prior radiotherapy of the mediastinal/pericardial area or whole pelvis radiation
  • Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction within 6 months of randomization 
  • QTc interval of >450 ms for males and >470 ms for females on ECG
  • Pregnant or breastfeeding
  • Known allergy to any of the treatment components
  • Known active bacterial, fungal, or viral infection, including HIV or hepatitis A, B, or C
*
This clinical trial is being conducted globally.
Olaratumab 20 mg/kg or placebo equivalent is administered intravenously (IV) on days 1 and 8 of cycle 1. Olaratumab 15 mg/kg is administered IV on days 1 and 8 of cycles 2-8 and continued until documented progressive disease or discontinuation for any reason.
Doxorubicin 75 mg/mis administered IV on day 1 of a 21-day cycle for 8 cycles.
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.