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

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

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 DiseaseIntervention/TreatmentPhase

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

ArmIntervention/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

SiteCityStateCountryPostal Code
1Asan Medical CenterSeoulKorea, Republic of138-736

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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 7, 2020