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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254267
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : February 27, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Gastrointestinal Stromal Tumor Drug: AMG 706 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Primary Completion Date : February 2007
Study Completion Date : December 2012


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm One
AMG 706 125mg, oral, once a day
Drug: AMG 706
AMG 706 125mg, oral, once a day


Outcome Measures

Primary Outcome Measures :
  1. The objective response rate as assessed by modified RECIST [ Time Frame: Every 8 weeks ]

Secondary Outcome Measures :
  1. Duration of response, progression-free survival, time to response, overall survival, PK and safety profile [ Time Frame: imaging, every 8 weeks; survival, every 6 months; PK, Days 1,15, 29, 43, 57, every 2 weeks in week 9 to 16, and every 4 weeks thereafter; ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00254267


Sponsors and Collaborators
Amgen
Takeda Bio Development Center, Ltd
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00254267     History of Changes
Other Study ID Numbers: 20050129
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: February 27, 2014
Last Verified: February 2014

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

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Niacinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs