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Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Amgen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00254267
First received: November 14, 2005
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  Purpose

The purpose of the study is to evaluate the safety and efficacy of AMG 706 in patients with gastrointestinal stromal tumor that have not been controlled while taking imatinib mesylate.


Condition Intervention Phase
Advanced Gastrointestinal Stromal Tumor
 Drug: AMG 706
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2 Study of AMG 706 in Japanese Subjects With Advanced Gastrointestinal Stromal Tumors (GISTs) Who Developed Progressive Disease or Relapsed While on Imatinib Mesylate

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The objective response rate as assessed by modified RECIST

Secondary Outcome Measures:
  • Duration of response, progression-free survival, time to response, overall survival, PK and safety profile

Estimated Enrollment: 35
Study Start Date: November 2005
Estimated Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of histological confirmed GIST
  • Had prior imatinib mesylate therapy
  • Has at least 1 measurable leasion by modified RECIST

Exclusion Criteria:

  • Central nervous system tumor involvement requiring treatment
  • History of myocardial infraction
  • Uncontrolled hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254267

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00254267     History of Changes
Other Study ID Numbers: 20050129
Study First Received: November 14, 2005
Last Updated: December 20, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:
Gastrointestinal Stromal Tumor, Imatinib Mesylate Resistance, Phase2 study, AMG 706

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013