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Study Complete
Sponsor ID
20060324

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

Sponsor ID
20060324
Clinicaltrials.gov ID
NCT00626704
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
conatumumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
134
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-Free Survival

Timeframe: Length of Study

Secondary Outcome Measures

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.

Timeframe: Length of Study

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Sarcoma
    • Sex
    All
    Trial Dates
    Nov 2007 - Aug 2009
    Inclusion and Exclusion 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