EUCTR2015-001316-34-HUActive, not recruitingPhase 1
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 - ANNOUNCE 2
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 310
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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