Status:
COMPLETED
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
Lead Sponsor:
Amgen
Conditions:
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This phase 1/2, multicenter, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with doxorubicin compared with doxorubicin alon...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed soft tissue sarcoma
- Locally advanced, recurrent, or metastatic, unresectable disease
- Measurable disease according to modified RECIST
- ECOG performance status of 0 or 1
- Men or women at least 18 years of age
- Adequate hematological, renal, hepatic, and coagulation function
Exclusion
- Prior treatment with anthracyclines
- Uncontrolled cardiovascular disease
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00626704
Start Date
November 1 2007
End Date
March 1 2011
Last Update
May 25 2015
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