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

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

MedlinePlus related topics:

Soft Tissue Sarcoma

ChemIDplus related topics:

Doxorubicin Doxorubicin hydrochloride Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

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:	90
Study Start Date:	November 2007
Estimated Study Completion Date:	March 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

Contacts


Contact: Amgen Call Center	866-572-6436

Locations


United States, Arizona
	Research Site	Recruiting
	Tucson, Arizona, United States

United States, California
	Research Site	Recruiting
	Duarte, California, United States
	Research Site	Recruiting
	Santa Monica, California, United States
	Research Site	Recruiting
	Stanford, California, United States
	Research Site	Recruiting
	Los Angelas, California, United States

United States, Illinois
	Research Site	Recruiting
	Evanston, Illinois, United States
	Research Site	Recruiting
	Chicago, Illinois, United States

United States, Maryland
	Research Site	Recruiting
	Baltimore, Maryland, United States

United States, Massachusetts
	Research Site	Recruiting
	Boston, Massachusetts, United States

United States, Minnesota
	Research Site	Recruiting
	Rochester, Minnesota, United States

United States, Oregon
	Research Site	Recruiting
	Portland, Oregon, United States

United States, Pennsylvania
	Research Site	Recruiting
	Radnor, Pennsylvania, United States
	Research Site	Recruiting
	Philadelphia, Pennsylvania, United States

United States, Tennessee
	Research Site	Recruiting
	Nashville, Tennessee, United States

Austria
	Research Site	Recruiting
	Wien, Austria

Belgium
	Research Site	Recruiting
	Brussel, Belgium
	Research Site	Recruiting
	Leuven, Belgium

France
	Research Site	Recruiting
	Villejuif, France
	Research Site	Recruiting
	Lyon, France
	Research Site	Recruiting
	Marseille, France

Netherlands
	Research Site	Recruiting
	Leiden, Netherlands
	Research Site	Recruiting
	Groningen, Netherlands

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20060324
First Received:	February 14, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00626704
Health Authority:	France: Afssaps - French Health Products Safety Agency; Netherlands: Medicines Evaluation Board; United States: Food and Drug Administration; Austria: Competant Authority; Belgium: FPS of Public Health, Food Chain Security and Environment

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

Study placed in the following topic categories:

Neoplasms, Connective and Soft Tissue

Antibodies

Death

Malignant mesenchymal tumor

Benzocaine

Sarcoma

Doxorubicin

Soft tissue sarcomas

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Antineoplastic Agents

Therapeutic Uses

Antibiotics, Antineoplastic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00626704