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

NCT ID: NCT00254267

Last Updated: 2014-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Gastrointestinal Stromal Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm One

AMG 706 125mg, oral, once a day

Group Type EXPERIMENTAL

AMG 706

Intervention Type DRUG

AMG 706 125mg, oral, once a day

Interventions

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AMG 706

AMG 706 125mg, oral, once a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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Benjamin RS, Schoffski P, Hartmann JT, Van Oosterom A, Bui BN, Duyster J, Schuetze S, Blay JY, Reichardt P, Rosen LS, Skubitz K, McCoy S, Sun YN, Stepan DE, Baker L. Efficacy and safety of motesanib, an oral inhibitor of VEGF, PDGF, and Kit receptors, in patients with imatinib-resistant gastrointestinal stromal tumors. Cancer Chemother Pharmacol. 2011 Jul;68(1):69-77. doi: 10.1007/s00280-010-1431-9. Epub 2010 Sep 14.

Reference Type DERIVED
PMID: 20838998 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20050129

Identifier Type: -

Identifier Source: org_study_id

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