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

NCT ID: NCT02185937

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Stromal Tumor Major Gastrectomy

Keywords

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imatinib gastrectomy gastrointestinal stromal tumor pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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water

imatinib intake with water

Group Type NO_INTERVENTION

No interventions assigned to this group

cola

imatinib intake with cola

Group Type ACTIVE_COMPARATOR

cola

Intervention Type DIETARY_SUPPLEMENT

imatinib intake with coca-cola

Interventions

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cola

imatinib intake with coca-cola

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Coca-cola

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nielka van Erp

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboudumc

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type RESULT
PMID: 28677263 (View on PubMed)

Other Identifiers

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ABILITY

Identifier Type: -

Identifier Source: org_study_id