A Study of Soft Tissue Sarcoma with Olaratumab, Gemcitabine and Docetaxel
Phase 1
- Conditions
- soft tissue sarcomaMedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001316-34-HU
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
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 Main Objective: Overall Survival (OS);Secondary Objective: Progression-Free Survival (PFS) ;Primary end point(s): Overall Survival;Timepoint(s) of evaluation of this end point: This study will be considered complete following final analysis of the OS endpoint (at least 108 OS events) has been performed and evaluated, as determined by Lilly.
- 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