Back to results

Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy (ABILITY)

Primary Purpose

Gastrointestinal Stromal Tumor, Major Gastrectomy

Status

Terminated

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

cola

About this trial

This is an interventional other trial for Gastrointestinal Stromal Tumor focused on measuring imatinib, gastrectomy, gastrointestinal stromal tumor, pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Radboudumc

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

water

cola

Arm Description

imatinib intake with water

imatinib intake with cola

Outcomes

Primary Outcome Measures

imatinib area under the curve

imatinib exposure assessed as area under the curve

Secondary Outcome Measures

number of adverse events

number of adverse events will be reported and compared for both treatments

Full Information

NCT ID

NCT02185937

First Posted

July 7, 2014

Last Updated

December 4, 2020

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02185937

Brief Title

Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy

Acronym

ABILITY

Official Title

Influence of an Acidic Beverage (Coca-Cola) on the Exposure to Imatinib (GLIvec) After Major gastrecTomY in Patients With Gastrointestinal Stromal Tumors (ABILITY)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Terminated

Why Stopped

inclusion was too slow

Study Start Date

August 2014 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 surgery which might affect imatinib exposure. Indeed, Yoo et al. showed that steady state imatinib trough levels in patients with advanced GISTs after major gastrectomy are lower compared to patients with a previous wedge resection or without gastric surgery. Patients that underwent major gastrectomy had an average imatinib plasma trough levels below 1000 µg/L. This while imatinib trough levels above 1000 µg/L are correlated to more beneficial treatment out-comes (longer Progression Free Survival). Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid secretion might be causing the decreased exposure in the patients that underwent major gastrectomy. Therefore the investigators would like to study if the exposure to imatinib in patients after major gastrectomy can be improved by creating a more acidic environment for absorption through combining imatinib intake with Coca-Cola.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrointestinal Stromal Tumor, Major Gastrectomy

Keywords

imatinib, gastrectomy, gastrointestinal stromal tumor, pharmacokinetics

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

water

Arm Type

No Intervention

Arm Description

imatinib intake with water

Arm Title

cola

Arm Type

Active Comparator

Arm Description

imatinib intake with cola

Intervention Type

Dietary Supplement

Intervention Name(s)

cola

Other Intervention Name(s)

Coca-cola

Intervention Description

imatinib intake with coca-cola

Primary Outcome Measure Information:

Title

imatinib area under the curve

Description

imatinib exposure assessed as area under the curve

Time Frame

day 7; predose - 10 hours after dosing

Secondary Outcome Measure Information:

Title

number of adverse events

Description

number of adverse events will be reported and compared for both treatments

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nielka van Erp

Organizational Affiliation

Radboud University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboudumc

City

Nijmegen

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

28677263

Citation

Lubberman FJE, Gelderblom H, Wilmer CM, Kweekel DM, Desar IME, Colbers A, Burger D, van der Graaf WTA, van Erp N. Does a glass of Coke boost the exposure to imatinib in gastrointestinal stromal tumour patients after gastrectomy? Br J Clin Pharmacol. 2017 Oct;83(10):2312-2314. doi: 10.1111/bcp.13333. Epub 2017 Jul 4. No abstract available.

Results Reference

result

Learn more about this trial

Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy

We'll reach out to this number within 24 hrs