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

NCT00626704 | Completed Phase 1

• 1 other identifier: 20060324
• Study Type: interventional
• Target: 134
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  Length of Study

Secondary Outcomes (1)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

AMG 655 + Doxorubicin

Drug: AMG 655; Drug: Doxorubicin

Arm 2

PLACEBO COMPARATOR

Placebo + Doxorubicin

Other: Placebo; Drug: Doxorubicin

Interventions

AMG 655 DRUG

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

Also known as: Conatumumab

Arm 1

Placebo OTHER

Inactive dummy AMG 655 (to maintain blind)

Arm 2

Doxorubicin DRUG

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

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior treatment with anthracyclines
• Uncontrolled cardiovascular disease

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasm Metastasis; Sarcoma

Interventions

conatumumab; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 29, 2008
• Study Start: November 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: March 1, 2011
• Last Updated: May 25, 2015

Record last verified: 2015-04