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

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ClinicalTrials.gov Identifier: NCT00976612
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):

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 disease Intervention/treatment
Gastrointestinal Stromal Tumors Drug: Nilotinib

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 : January 2009
Primary Completion Date : August 2011
Study Completion Date : December 2011


Groups and Cohorts

Group/Cohort Intervention/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 [ Time Frame: Up to 3years ]

Biospecimen Retention:   Samples Without DNA
blood about 4ml

Eligibility Criteria

Information from the National Library of Medicine

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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.
Criteria

Inclusion Criteria:

  • Patients with metastatic or unresectable gastrointestinal stromal tumor
  • Patients receiving nilotinib after failure to imatinib and sunitinib
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yoon-Koo Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00976612     History of Changes
Other Study ID Numbers: AMC-ONCGI-0901
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors