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Completed Phase 1 Interventional Results available

Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)

ClinicalTrials.gov ID: NCT03291288

Public ClinicalTrials.gov record NCT03291288. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 12:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-label, Single Sequence, Crossover Drug-drug Interaction Study Assessing the Effect of Pexidartinib on the Pharmacokinetics of CYP3A4 and CYP2C9 Substrates in Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study has two parts. Part 1 will evaluate how pexidartinib affects the way the body processes CYP3A4 and CYP2C9 substrates using midazolam and tolbutamide, respectively, as probe agents. Part 2 will test the efficacy and safety of pexidartinib treatment in various tumor types. In Part 2, the same participants will continue to receive pexidartinib twice daily. Participants will be allowed to continue using pexidartinib as long as the participant derives benefit.

Study identification

NCT ID
NCT03291288
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Daiichi Sankyo
Industry
Enrollment
32 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 25, 2018
Primary completion
Sep 25, 2018
Completion
Apr 15, 2021
Last update posted
May 13, 2021

2018 – 2021

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
HonorHealth Scottsdale Arizona 85258
University of Arizona Tucson Arizona 85719
Stanford University Palo Alto California 94304
University of Kansas Cancer Center Westwood Kansas 66205
Dana-Farber Cancer Institute Boston Massachusetts 02215
Karmanos Cancer Center Detroit Michigan 48201
Northwell Health Lake Success New York 10042
Mary Crowley Cancer Research Dallas Texas 75230

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03291288, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2021 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03291288 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →