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

  • Cancer
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT03330990 GO40785 RXDX-101-14

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03330990 , RXDX-101-14 , GO40785 Trial Identifier
      Entrectinib, Midazolam Hydrochloride Treatments
      Advanced Solid Tumor Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      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.

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