A Study of Soft Tissue Sarcoma with Olaratumab, Gemcitabine and Docetaxel

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 310

Inclusion Criteria

Patients at least 16 years of age, ECOG PS 0 to 1, gemcitabine, docetaxel, and olaratumab naïve, with histologically confirmed, locally advanced, unresectable or metastatic STS, and not amenable to curative treatment with surgery or radiotherapy. The patient 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 locally advanced or metastatic disease and is suitable to receive gemcitabine and docetaxel therapy. All previous anticancer treatments must have completed = 3 weeks (21 days) prior to first dose of study drug. In the phase 2 part, 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 2 full cycles of olaratumab/doxorubicin (i.e. a minimum of 4 doses of olaratumab). Patients who completed at least 2 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 174
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

Patients with gastrointestinal stromal tumor or Kaposi’s sarcoma will be excluded. Patients previously enrolled in Study I5B-MC-JGDJ or any other blinded study with olaratumab are not eligible to participate in this trial.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: This study will be considered complete (that is, the scientific evaluation will be complete [study completion]) following final analysis of the OS<br>endpoint (at least 108 OS events in the olaratumab naïve arm) has been performed and evaluated, as determined by Lilly. Investigators will<br>continue to follow the study schedule for all patients until notified by Lilly that study completion has occurred.;Main Objective: Overall Survival (OS);Secondary Objective: Progression-Free Survival (PFS) ;Primary end point(s): Overall Survival

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Progression Free Survival (OS);Timepoint(s) of evaluation of this end point: Conclusion of phase II trial

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