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NCT00626704 Clinical Trial

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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00626704
Other study ID # 20060324
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 14, 2008
Last updated May 7, 2015
Start date November 2007
Est. completion date March 2011

Study information
Verified date April 2015
Source Amgen
Contact n/a
Is FDA regulated No
Health authority Austria: Competant AuthorityBelgium: FPS of Public Health, Food Chain Security and EnvironmentFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Netherlands: Medicines Evaluation BoardUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 134
Est. completion date March 2011
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Other:
• Placebo
Inactive dummy AMG 655 (to maintain blind)
Drug:
• Doxorubicin
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-Free Survival Length of Study No
Secondary 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. Length of Study No
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