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

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Nilotinib

• Registration Number: NCT00976612
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients with metastatic or unresectable gastrointestinal stromal tumor
• Patients receiving nilotinib after failure to imatinib and sunitinib

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nilotinib	Nilotinib	Patients who receive nilotinib with failure to both imatinib and sunitinib

Primary Outcome Measures

Name	Time	Method
nilotinib pharmacokinetics	Up to 3years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of