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

• Sponsor: Asan Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00976612
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Stromal Tumors	Drug: Nilotinib

Study Design

• Study Type: Observational
• Actual Enrollment: 17 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pharmacokinetic Study of Nilotinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Showing Failure to Both Imatinib and Sunitinib
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Nilotinib Patients who receive nilotinib with failure to both imatinib and sunitinib	Drug: Nilotinib; Nilotinib 400mg bid daily

Outcome Measures

Primary Outcome Measures

1. nilotinib pharmacokinetics [Up to 3years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with metastatic or unresectable gastrointestinal stromal tumor

• Patients receiving nilotinib after failure to imatinib and sunitinib

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul		Korea, Republic of	138-736

Sponsors and Collaborators

• Asan Medical Center

Investigators

• Principal Investigator: Yoon-Koo Kang, M.D., PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT00976612
• Other Study ID Numbers: AMC0901
• First Posted: Sep 14, 2009
• Last Update Posted: Jan 7, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Yoon-Koo Kang, Professor, Asan Medical Center: Gastrointestinal stromal tumor; pharmacokinetics; nilotinib
• Additional relevant MeSH terms: Gastrointestinal Stromal Tumors

Study Results

No Results Posted as of Jan 7, 2020