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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00976612
First received: September 11, 2009
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention
Gastrointestinal Stromal Tumors
 Drug: Nilotinib

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Nilotinib
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Biospecimen Retention:   Samples Without DNA

blood about 4ml


Enrollment: 17
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Nilotinib
Patients who receive nilotinib with failure to both imatinib and sunitinib
 Drug: Nilotinib
Nilotinib 400mg bid daily

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with metastatic or unresectable gastrointestinal stromal tumor who failed to imatinib and sunitinib.

Criteria

Inclusion Criteria:

  • Patients with metastatic or unresectable gastrointestinal stromal tumor
  • Patients receiving nilotinib after failure to imatinib and sunitinib
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976612

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00976612     History of Changes
Other Study ID Numbers: AMC0902
Study First Received: September 11, 2009
Last Updated: August 1, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Gastrointestinal stromal tumor
pharmacokinetics
nilotinib

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013