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

Amgen134 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

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

Interventions

AMG 655DRUG

AMG 655 is an investigational, fully human monoclonal agonist antibody that selectively binds to Death Receptor-5 (DR5).

PlaceboOTHER

Inactive dummy AMG 655 (to maintain blind)

DoxorubicinDRUG

Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Progression-Free Survival

Time frame: Length of Study

Secondary Outcomes

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

Data from ClinicalTrials.gov

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