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

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ClinicalTrials.gov Identifier: NCT00254267
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : February 27, 2014
Sponsor:
Collaborator:
Takeda Bio Development Center, Ltd
Information provided by (Responsible Party):
Amgen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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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
Actual Primary Completion Date : February 2007
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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