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

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

October 29, 2009

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00626704 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Efficacy and safety endpoints [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
Sarcoma
Soft Tissue Sarcoma

Intervention ^ICMJE

Drug: AMG 655
Other: Placebo

Study Arms / Comparison Groups

Experimental: AMG 655 + Doxorubicin
Placebo Comparator: Placebo + Doxorubicin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

May 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, France, Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00626704

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20060324

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP