A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic So… (NCT02451943) | Clinical Trial Compass
CompletedPhase 3
A Study of Doxorubicin Plus Olaratumab (LY3012207) in Participants With Advanced or Metastatic Soft Tissue Sarcoma
United States509 participantsStarted 2015-09-14
Plain-language summary
The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of advanced unresectable or metastatic soft tissue sarcoma not amenable to curative treatment with surgery or radiotherapy. Participants with Kaposi's sarcoma and gastrointestinal stromal tumors (GIST) will be excluded. Note: Evidence of disease progression is required for participants that are not newly diagnosed.
* Presence of measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1, Eisenhauer et al. 2009).
* Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* The participant has not received any previous treatment with anthracyclines.
* The participant may have had any number of prior systemic cytotoxic therapies for advanced/metastatic disease and are considered appropriate candidates for anthracycline therapy. All previous anticancer treatments must be completed ≥ 3 weeks (21 days) prior to first dose of study drug.
* Availability of tumor tissue is required for study eligibility. The participant must have consented to provide archived formalin-fixed paraffin embedded (FFPE) 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).
* Adequate hematologic, organ, and coagulation within 2 weeks (14 days) prior to randomization.
* Left ventricular ejection fraction (LVEF) ≥50% assessed w…
What they're measuring
1
Overall Survival (OS)
Timeframe: Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)
2
Overall Survival (OS) Leiomyosarcoma (LMS)
Timeframe: Randomization to Date of Death Due to Any Cause (Up to 35.8 Months)