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

This study has been completed.
Information provided by (Responsible Party):
Yoon-Koo Kang, Asan Medical Center Identifier:
First received: September 11, 2009
Last updated: July 3, 2013
Last verified: July 2013
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:

Further study details as provided by Yoon-Koo Kang, Asan Medical Center:

Primary Outcome Measures:
  • nilotinib pharmacokinetics [ Time Frame: Up to 3years ]

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
Patients who receive nilotinib with failure to both imatinib and sunitinib
Drug: Nilotinib
Nilotinib 400mg bid daily


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.

Inclusion Criteria:

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

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Principal Investigator: Yoon-Koo Kang, M.D., PhD Asan Medical Center
  More Information

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center Identifier: NCT00976612     History of Changes
Other Study ID Numbers: AMC-ONCGI-0901
Study First Received: September 11, 2009
Last Updated: July 3, 2013

Keywords provided by Yoon-Koo Kang, Asan Medical Center:
Gastrointestinal stromal tumor

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on September 20, 2017