Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST): Nilotinib PK

NCT ID: NCT00976612

Last Updated: 2020-01-07

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

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. The relationship between surgery type and nilotinib pharmakokinetic properties will be investigated in this study.

Detailed Description

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Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nilotinib

Patients who receive nilotinib with failure to both imatinib and sunitinib

Nilotinib

Intervention Type DRUG

Nilotinib 400mg bid daily

Interventions

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Nilotinib

Nilotinib 400mg bid daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with metastatic or unresectable gastrointestinal stromal tumor
* Patients receiving nilotinib after failure to imatinib and sunitinib
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yoon-Koo Kang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoon-Koo Kang, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMC0901

Identifier Type: -

Identifier Source: org_study_id

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