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

This study is currently recruiting participants.

Verified September 2011 by Asan Medical Center

First Received on September 11, 2009. Last Updated on September 28, 2011 History of Changes

Sponsor:	Asan Medical Center
Information provided by (Responsible Party):	Yoon-Koo Kang, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00976612

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:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Biospecimen Retention: Samples Without DNA

blood about 4ml

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976612

Contacts

Contact: Yoon-Koo Kang, MD, PhD	82-2-3010-3230	ykkang@amc.seoul.kr
Contact: Min-Hee Ryu, MD, PhD	82-2-3010-5935	miniryu@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Yoon-Koo Kang, MD, PhD 82-2-3010-3230 ykkang@amc.seoul.kr
Contact: Min-Hee Ryu, MD, PhD 82-2-3010-5935 miniryu@amc.seoul.kr

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:	September 28, 2011
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
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 09, 2012