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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00626704

Enrollment

134

Registered

2008-02-29

Start date

2007-11-30

Completion date

2011-03-31

Last updated

2015-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGAMG 655

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

OTHERPlacebo

Inactive dummy AMG 655 (to maintain blind)

DRUGDoxorubicin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival	Length of Study

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026