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Completed

NCT Number: NCT03330990

Evaluate the Effect of Entrectinib on the Pharmacokinetics of 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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SCRI-Denver Drug Development Program, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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.

Treatment and study plan

Entrectinib

Drug

600 mg oral capsule (fasted and fed)

Midazolam Hydrochloride

Drug

2 mg oral syrup (fasted)

Primary outcomes

  1. AUClast

    Time frame: 4 weeks

    Area under the concentration-time curve from 0 to the last measurable concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.

  2. AUCinf

    Time frame: 4 weeks

    Area under the concentration-time curve from 0 to infinity of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.

  3. Cmax

    Time frame: 4 weeks

    Peak plasma concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.

  4. Tmax

    Time frame: 4 weeks

    Time of maximum concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.

  5. t1/2

    Time frame: 4 weeks

    Terminal half-life of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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