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

  • Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:


This trial runs in
  • Denver
  • Nashville
  • Sarasota
Trial Identifier:

NCT03330990 GO40785 RXDX-101-14

      Show trial locations

      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      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:

      • 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.

      About Clinical Research

      What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

      Find out now