Trial Information
A Phase 1b/2 Study of AMG 655 in Combination With Doxorubicin for the First-Line Treatment of Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Inclusion Criteria:
- 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 Criteria:
- Prior treatment with anthracyclines
- Uncontrolled cardiovascular disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Progression-Free Survival
Outcome Time Frame:
Length of Study
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Austria: Competant Authority
Study ID:
20060324
NCT ID:
NCT00626704
Start Date:
November 2007
Completion Date:
May 2012
Related Keywords:
- Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
- Sarcoma
- Soft Tissue Sarcoma
- Sarcoma
- Soft Tissue Sarcoma
- Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
- AMG 655
- STS
- Doxorubicin
- Death receptor
- TRAIL receptor
- Apoptosis
- Sarcoma