Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST)
This study has been completed.
Sponsor:
Asan Medical Center
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2009 | ||||
| Last Updated Date | August 1, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00976612 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST) | ||||
| Official Title ICMJE | Pharmacokinetic Study of Nilotinib in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor Showing Failure to Both Imatinib and Sunitinib | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: blood about 4ml |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with metastatic or unresectable gastrointestinal stromal tumor who failed to imatinib and sunitinib. |
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| Condition ICMJE | Gastrointestinal Stromal Tumors | ||||
| Intervention ICMJE | Drug: Nilotinib
Nilotinib 400mg bid daily |
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| Study Group/Cohort (s) | Nilotinib
Patients who receive nilotinib with failure to both imatinib and sunitinib
Intervention: Drug: Nilotinib |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 17 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00976612 | ||||
| Other Study ID Numbers ICMJE | AMC0902 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Yoon-Koo Kang, Asan Medical Center | ||||
| Study Sponsor ICMJE | Asan Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asan Medical Center | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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