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

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ClinicalTrials.gov Identifier: NCT00626704
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma Sarcoma Soft Tissue Sarcoma Drug: AMG 655 Other: Placebo Drug: Doxorubicin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : March 2011


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



Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Length of Study ]

Secondary Outcome Measures :
  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. [ Time Frame: Length of Study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626704


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00626704     History of Changes
Other Study ID Numbers: 20060324
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: April 2015

Keywords provided by Amgen:
Sarcoma
Soft Tissue Sarcoma
Locally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
AMG 655
STS
Doxorubicin
Death receptor
TRAIL receptor
Apoptosis

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action