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Study of AMN107 With Imatinib in Gastrointestinal Stromal Tumors (GIST)

NCT ID: NCT00135005

Last Updated: 2020-12-08

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

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-11-30

Brief Summary

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This study is an open-label, multicenter, Phase I dose-escalation study of the combination of AMN107 and imatinib (STI571) in patients with imatinib-resistant GIST. This study is designed to determine the Phase II dose of AMN107 and imatinib when administered together in patients with imatinib-resistant GIST, and to characterize the safety, tolerability and pharmacokinetic (PK) profile of this combination.

Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors

Keywords

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GIST AMN107 Gastrointestinal Stromal Tumors

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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AMN107 + STI571

Group Type EXPERIMENTAL

AMN107, STI571

Intervention Type DRUG

Interventions

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AMN107, STI571

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with gastrointestinal stromal tumor (GIST).
* Patients who have had disease progression during imatinib therapy with 800 mg.
* Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

* Patients with prior or concomitant malignancies other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ.
* A history of impaired cardiac function or uncontrolled cardiovascular disease.
* Severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AMN107.
* Currently taking certain medications that could affect an electrocardiogram result.
* Women who are pregnant or breast feeding.
* Patients unwilling or unable to comply with the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Boston, Massachusetts, United States

Site Status

Novartis Investigative Site

Philadelphia, Pennsylvania, United States

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Countries

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United States France Germany Italy

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2942

Results for CAMN107A2103 can be found on the Novartis Clinical Trial Results Website

Other Identifiers

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2005-000561-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAMN107A2103

Identifier Type: -

Identifier Source: org_study_id