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.
ANNOUNCE 2; NCT02659020
A Phase 1b (Open-Label)/Phase 2 (Randomized, Double-Blinded) Study Evaluating Gemcitabine and Docetaxel With or Without Olaratumab in the Treatment of Advanced Soft Tissue Sarcoma*
Key Inclusion Criteria
- No more than two prior lines of systemic therapies (neoadjuvant/adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and should be suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ≥3 weeks (21 days) prior to first dose of study drug
- Phase 2: Prior olaratumab/doxorubicin combination therapy in one prior treatment line is allowed
- Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label
- Prior olaratumab therapy must have included at least two full cycles of olaratumab/doxorubicin (ie, a minimum of four doses of olaratumab)
- Participants who completed at least two cycles of combination olaratumab/doxorubicin therapy, then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy, are eligible
- The most recent dose of olaratumab must have been received within 180 days of randomization in this study
- Availability of tumor tissue or willing to undergo a pretreatment biopsy of primary or metastatic tumor for future central pathology review and translational research (if archived tissue is unavailable)
- Adequate hematologic, organ, and coagulation function within 2 weeks (14 days) prior to enrollment or randomization
Key Exclusion Criteria
- Gastrointestinal stromal tumor or Kaposi sarcoma
- Active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of enrollment or randomization. Participants with a history of a CNS metastasis previously treated with curative intent (eg, stereotactic radiation or surgery), who have not progressed on follow-up imaging, have been asymptomatic for at least 60 days, and are not receiving systemic corticosteroids and/or anticonvulsants, are eligible. Participants with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before enrollment or randomization to rule out brain metastasis
- Prior treatment with gemcitabine or docetaxel. Participants previously enrolled in I5B-MC-JGDJ (NCT02451943) or any other blinded study with olaratumab are not eligible to participate in this trial
- Electively planned or will require major surgery during the course of the study
- Pregnant or breastfeeding
- Active symptomatic fungal, bacterial, or viral infection, including HIV or hepatitis A, B, or C
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.