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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 ongoing, but not recruiting participants.
First Received: February 14, 2008   Last Updated: December 17, 2009   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00626704
  Purpose

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
Sarcoma
Soft Tissue Sarcoma
 Drug: AMG 655
Other: Placebo
 Phase I
Phase II

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:

MedlinePlus related topics: Soft Tissue Sarcoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride
U.S. FDA Resources

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 ]

Estimated Enrollment: 120
Study Start Date: November 2007
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental
AMG 655 + Doxorubicin
Drug: AMG 655
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Arm 2: Placebo Comparator
Placebo + Doxorubicin
Other: Placebo
Inactive dummy AMG 655 (to maintain blind)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626704

Locations
United States, Arizona
Research Site
Tucson, Arizona, United States
United States, California
Research Site
Duarte, California, United States
Research Site
Los Angeles, California, United States
Research Site
Santa Monica, California, United States
Research Site
Stanford, California, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
Research Site
Evanston, Illinois, United States
United States, Maryland
Research Site
Baltimore, Maryland, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United States, Minnesota
Research Site
Rochester, Minnesota, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Austria
Research Site
Wien, Austria
Belgium
Research Site
Bruxelles, Belgium
Research Site
Leuven, Belgium
France
Research Site
Lyon, France
Research Site
Marseille, France
Research Site
Villejuif, France
Netherlands
Research Site
Groningen, Netherlands
Research Site
Leiden, Netherlands
Research Site
Nijmegen, Netherlands
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20060324
Study First Received: February 14, 2008
Last Updated: December 17, 2009
ClinicalTrials.gov Identifier: NCT00626704     History of Changes
Health Authority: Austria: Competant Authority;   Belgium: FPS of Public Health, Food Chain Security and Environment;   France: Afssaps - French Health Products Safety Agency;   Netherlands: Medicines Evaluation Board;   United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
 Sarcoma
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin

ClinicalTrials.gov processed this record on March 18, 2010



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