A Phase 1b (Open-Label) / Phase 2 (Randomized,Double-Blinded) Study Evaluating Gemcitabine andDocetaxel With or Without Olaratumab in the Treatment ofAdvanced Soft Tissue Sarcoma

Protocol: 
AAAQ8127
Phase: 
I/II

A Phase 1b (Open-Label) / Phase 2 (Randomized,Double-Blinded) Study Evaluating Gemcitabine andDocetaxel With or Without Olaratumab in the Treatment ofAdvanced Soft Tissue Sarcoma

The primary objective of the Phase 1b part is to determine a recommended Phase 2 dose of olaratumab that may be safely administered in combination with gemcitabine and docetaxel to patients with advanced or metastatic STS. The primary objective of the Phase 2 part is to compare the overall survival (OS) in patients with advanced or metastatic STS treated with olaratumab plus gemcitabine and docetaxel versus placebo plus gemcitabine and docetaxel.

Are you Eligible? (Inclusion Criteria)

1) The patient has histologically confirmed diagnosis of locally advanced,
unresectable or metastatic STS not amenable to curative treatment with
surgery or radiotherapy.
2) The patient may have no more than 2 prior lines of systemic therapies
for advanced or metastatic disease and is suitable to receive
gemcitabine and docetaxel therapy.
3) Availability of tumor tissue is mandatory for study eligibility.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States