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Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma

This study is currently recruiting participants.
Study NCT00626704.   Last updated on October 30, 2008.   Information provided by Amgen

This Tabular View shows the required WHO registration data elements as marked by †

Descriptive Information Fields
Brief Title † Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
Official Title † 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
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 alone in subjects with previously untreated, locally advanced or metastatic, unresectable soft tissue sarcoma.
Detailed Description
Study Phase Phase I, Phase II
Study Type † Interventional
Study Design † Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure † Progression-Free Survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Secondary Outcome Measure † Objective response rate, time to response, duration of response, clinical benefit rate, overall survival, incidence of adverse events and clinical laboratory abnormalities, and incidence of anti-AMG 655 antibody formation. [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Condition † Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Sarcoma
Soft Tissue Sarcoma
Intervention † Drug: AMG 655
Other: Placebo
MEDLINE PMIDs
Links AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status † Recruiting
Enrollment † 120
Start Date † November 2007
Completion Date March 2012
Eligibility Criteria †

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Amgen Call Center     866-572-6436        
Location Countries † United States,   Austria,   Belgium,   France,   Netherlands
Administrative Information Fields
NCT ID † NCT00626704
Organization ID 20060324
Secondary IDs ††
Study Sponsor † Amgen
Collaborators ††
Investigators †
Study Director:     MD     Amgen    
Information Provided By Amgen
Verification Date October 2008
First Received Date † February 14, 2008
Last Updated Date October 30, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.

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