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
  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:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • nilotinib pharmacokinetics [ Time Frame: Up to 3years ] [ Designated as safety issue: No ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: AMC-ONCGI-0901
Study First Received: September 11, 2009
Last Updated: July 3, 2013
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
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on October 30, 2014