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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 has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: February 14, 2008
Last updated: May 7, 2015
Last verified: April 2015
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.

Condition Intervention Phase
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Soft Tissue Sarcoma
Drug: AMG 655
Other: Placebo
Drug: Doxorubicin
Phase 1
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

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. [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: November 2007
Study Completion Date: March 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
AMG 655 + Doxorubicin
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Other Name: Conatumumab
Drug: Doxorubicin
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.
Placebo Comparator: Arm 2
Placebo + Doxorubicin
Other: Placebo
Inactive dummy AMG 655 (to maintain blind)
Drug: Doxorubicin
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00626704

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen Identifier: NCT00626704     History of Changes
Other Study ID Numbers: 20060324 
Study First Received: February 14, 2008
Last Updated: May 7, 2015
Health Authority: Austria: Competant Authority
Belgium: FPS of Public Health, Food Chain Security and Environment
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medicines Evaluation Board
United States: Food and Drug Administration

Keywords provided by Amgen:
Soft Tissue Sarcoma
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
AMG 655
Death receptor
TRAIL receptor

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016