Back to resultsPhase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
Primary Purpose
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, Sarcoma, Soft Tissue Sarcoma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AMG 655
Placebo
Doxorubicin
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma focused on measuring Sarcoma, Soft Tissue Sarcoma, Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, AMG 655, STS, Doxorubicin, Death receptor, TRAIL receptor, Apoptosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
AMG 655 + Doxorubicin
Placebo + Doxorubicin
Outcomes
Primary Outcome Measures
Progression-Free Survival
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00626704
Brief Title
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, Sarcoma, Soft Tissue Sarcoma
Keywords
Sarcoma, Soft Tissue Sarcoma, Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, AMG 655, STS, Doxorubicin, Death receptor, TRAIL receptor, Apoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
AMG 655 + Doxorubicin
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Placebo + Doxorubicin
Intervention Type
Drug
Intervention Name(s)
AMG 655
Other Intervention Name(s)
Conatumumab
Intervention Description
AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Inactive dummy AMG 655 (to maintain blind)
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.
Primary Outcome Measure Information:
Title
Progression-Free Survival
Time Frame
Length of Study
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
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