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

Sponsored by:	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:	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

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet

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

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:	January 22, 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

Study placed in the following topic categories:

Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Antibodies
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor

Death
Benzocaine
Sarcoma
Doxorubicin
Immunoglobulins

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 July 02, 2009