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Pharmacokinetic Boosting of Osimertinib

NCT03858491 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-09-26

No results posted yet for this study

Summary

The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Cobicistat

Cobicistat will be added to the treatment with osimertinib. The initial dose will be 150 mg cobicistat, which equals the dose used in the treatment of HIV-infected patients. If this dose is well tolerated and the increase in exposure of osimertinib is not sufficient, the dose of cobicistat will gradually be escalated to 600 mg per day (150 mg cobicistat, four times per day).

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Academisch Ziekenhuis Maastricht

    lead OTHER

Principal Investigators

  • Sander Croes, MSc, PhD · Maastricht University Medical Centre+ (MUMC+)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858491 on ClinicalTrials.gov