Status:
TERMINATED
Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy
Lead Sponsor:
Radboud University Medical Center
Conditions:
Gastrointestinal Stromal Tumor
Major Gastrectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The most common sites for GIST to occur are the stomach (60-70%) and proximal small intestines (20-25%). Therefore patients with GIST often have altered GI-tract due to tumor resection or palliative s...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years of age
- Patients with GIST, who previously underwent major gastrectomy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- Already selected to receive imatinib therapy in a dose of 400-800mg imatinib daily, as judged by the treating physician and with respect for and in agreement with the registration guidelines
- Subject is able and willing to sign the Informed Consent Form prior to screening
Exclusion
- Concomitant administration of any anti-cancer therapies (e.g. chemo-therapy, other targeted therapy, experimental drug, etc) other than imatinib
- Concomitant use of medication which strongly inhibits or induces CYP3A4
- Refractory nausea and vomiting, malabsorption with other causes than gastrectomy or external biliary shunt that would preclude adequate absorption.
- Unwillingness to use Coca-Cola
- Unwillingness or inability to swallow whole tablets
- Inability to comply with the requirements of the protocol
- Inability to understand the nature and extent of the study and the procedures required
- Participation in a drug study within 60 days prior to the first day of this study
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02185937
Start Date
August 1 2014
End Date
November 1 2016
Last Update
December 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Radboudumc
Nijmegen, Netherlands