NCT00976612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

2.6 years

First QC Date

September 11, 2009

Last Update Submit

January 6, 2020

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal stromal tumorpharmacokineticsnilotinib

Outcome Measures

Primary Outcomes (1)

  • nilotinib pharmacokinetics

    Up to 3years

Study Arms (1)

Nilotinib

Patients who receive nilotinib with failure to both imatinib and sunitinib

Drug: Nilotinib

Interventions

NilotinibDRUG

Nilotinib 400mg bid daily

Nilotinib

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood about 4ml

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Yoon-Koo Kang, M.D., PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

KR(1)