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

Phase 1

Completed

• Conditions: Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma; Sarcoma; Soft Tissue Sarcoma
• Interventions: Other: Placebo; Drug: AMG 655; Drug: Doxorubicin

• Registration Number: NCT00626704
• Lead Sponsor: Amgen

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

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-29
• Primary Completion: 2009-08
• Study Completion: 2011-03
• Disposition First Submitted: 2015-03-24
• Disposition First Submitted QC: 2015-03-24
• Status Verified: 2015-04
• Disposition First Posted: 2015-04-14
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

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Exclusion Criteria

• Prior treatment with anthracyclines
• Uncontrolled cardiovascular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Doxorubicin	Placebo + Doxorubicin
Arm 2	Placebo	Placebo + Doxorubicin
Arm 1	AMG 655	AMG 655 + Doxorubicin
Arm 1	Doxorubicin	AMG 655 + Doxorubicin

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	Length of Study

Secondary Outcome Measures

Name	Time	Method
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.	Length of Study