The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.
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
Soft Tissue SarcomaGemcitabineDocetaxel
You can join if…
Open to people ages 16 years and up
The participant may have no more than 2 prior lines of systemic therapies(neoadjuvant and adjuvant therapies will not be considered as a prior line of therapy) for advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous therapies must have completed ≥ 4 weeks (28 days)prior to enrollment (Phase 1b) / randomization (Phase 2).
Availability of tumor tissue is mandatory for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue or be subject to a pre-treatment re-biopsy of primary or metastatic tumor tissue for future central pathology review and translational research (if archived tissue is unavailable).
The participant has adequate hematologic, organ, and coagulation function within 2 weeks (14 days) prior to enrollment (Phase 1b) or randomization (Phase 2).
You CAN'T join if...
The participant is diagnosed with gastrointestinal stromal tumor (GIST) or Kaposi sarcoma.
The participant has active central nervous system (CNS) or leptomeningeal metastasis(brain metastasis) at the time of enrollment (Phase 1b) or randomization (Phase 2).Participants with a history of a CNS metastasis previously treated with curative intent (for example, stereotactic radiation or surgery) that 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 (Phase 1b) /randomization (Phase 2) to rule out brain metastasis.
The participant has received prior treatment with gemcitabine, docetaxel, and/or olaratumab. Note: Participants previously enrolled in the I5B-MC-JGDJ (NCT02451943)or any other blinded study with olaratumab are not eligible to participate in this trial.
The participant has electively planned or will require major surgery during the course of the study.
Females who are pregnant or breastfeeding.
The participant has an active fungal, bacterial, and/or known viral infection including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis(screening is not required).
Univ of California San Franciscoaccepting new patients San Francisco, California, 94115, USA
UCLA Medical Centeraccepting new patients Santa Monica, California, 90404, USA