Status:
COMPLETED
Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Patients must meet the following criteria in order to be included in the research study:
- 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.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1.
- Adequate hematologic, liver and renal function.
- Ability to understand the nature of this study and give written informed consent.
Exclusion
- Patients who meet any of the following criteria will be excluded from study entry:
- Participation in another therapeutic clinical trial within 28 days prior to start of midazolam administration.
- Prior treatment with entrectinib.
- Known hypersensitivity or intolerance to midazolam or oral formulation excipients, including allergy to cherries.
- 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.
- History of non-pharmacologically induced prolonged QTc interval (e.g., repeated demonstration of a QTc interval \> 500 milliseconds from ECGs).
- 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).
- Other Protocol defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03330990
Start Date
November 14 2017
End Date
July 11 2018
Last Update
August 21 2018
Active Locations (3)
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1
SCRI-Denver Drug Development Program
Denver, Colorado, United States, 80218
2
Florida Cancer Specialists - Sarasota (North Catttlemen Rd)
Sarasota, Florida, United States, 34232
3
Tennessee Oncology
Nashville, Tennessee, United States, 37203