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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: July 3, 2013
Last verified: July 2013

September 11, 2009
July 3, 2013
January 2009
August 2011   (final data collection date for primary outcome measure)
nilotinib pharmacokinetics [ Time Frame: Up to 3years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00976612 on ClinicalTrials.gov Archive Site
Not Provided
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Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST)
Pharmacokinetic Study of Nilotinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Showing Failure to Both Imatinib and Sunitinib

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood about 4ml

Non-Probability Sample

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

Gastrointestinal Stromal Tumors
Drug: Nilotinib
Nilotinib 400mg bid daily
Nilotinib
Patients who receive nilotinib with failure to both imatinib and sunitinib
Intervention: Drug: Nilotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
December 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with metastatic or unresectable gastrointestinal stromal tumor
  • Patients receiving nilotinib after failure to imatinib and sunitinib
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00976612
AMC-ONCGI-0901
No
Yoon-Koo Kang, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Yoon-Koo Kang, M.D., PhD Asan Medical Center
Asan Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP