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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

Pharmacokinetic Study of Nilotinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Showing Failure to Both Imatinib and Sunitinib

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976612
• Other study ID #: AMC0901
• Status: Completed
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: January 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients with metastatic or unresectable gastrointestinal stromal tumor

• Patients receiving nilotinib after failure to imatinib and sunitinib

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Nilotinib
Nilotinib 400mg bid daily

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nilotinib pharmacokinetics		Up to 3years