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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: AMG 655
* Other: Placebo
* Drug: Doxorubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>AMG 655 + Doxorubicin | Drug: AMG 655<br>* AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).<br>* Other names: Conatumumab;Drug: Doxorubicin<br>* Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.<br>|
| Placebo Comparator: Arm 2<br>Placebo + Doxorubicin | Other: Placebo<br>* Inactive dummy AMG 655 (to maintain blind)<br>Drug: Doxorubicin<br>* Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | Length of Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, Soft Tissue Sarcoma, Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma, AMG 655, STS, Doxorubicin, Death receptor, TRAIL receptor, Apoptosis