Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients



Status:Completed
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:November 14, 2017
End Date:July 11, 2018

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A Phase 1 Study to Evaluate the Potential Pharmacokinetic Interaction Between Entrectinib and Midazolam in Cancer Patients

This is an open-label study in advanced solid tumor patients to determine if entrectinib
affects the pharmacokinetics of midazolam and any of its pharmacologically active
metabolites.


Inclusion Criteria:

Patients must meet the following criteria in order to be included in the research study:

1. Histologically or cytologically confirmed diagnosis of advanced or metastatic solid
tumors that are not responsive to standard therapies or for which there is no
effective therapy.

2. At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior
chemotherapy or small molecule targeted therapy, respectively, at the time of the
start of midazolam administration.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1.

4. Adequate hematologic, liver and renal function.

5. Ability to understand the nature of this study and give written informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from study entry:

1. Participation in another therapeutic clinical trial within 28 days prior to start of
midazolam administration.

2. Prior treatment with entrectinib.

3. Known hypersensitivity or intolerance to midazolam or oral formulation excipients,
including allergy to cherries.

4. Any condition (in the past 3 months) that may interfere with the conduct of study
assessments or may interfere with the interpretation of study results.

5. History of non-pharmacologically induced prolonged QTc interval (e.g., repeated
demonstration of a QTc interval > 500 milliseconds from ECGs).

6. Known active infections that may interfere with the conduct of study assessments or
may interfere with the interpretation of study results (bacterial, fungal, or viral,
including human immunodeficiency virus positive).

7. Other Protocol defined Inclusion/Exclusion criteria apply.
We found this trial at
3
sites
600 North Cattlemen Road
Sarasota, Florida 34232
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Denver, Colorado 80218
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Todd M. Bauer, MD
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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