Clinical trial · Interventional
Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients
A Phase 1 Study to Evaluate the Potential Pharmacokinetic Interaction Between Entrectinib and Midazolam in Cancer Patients
NCT03330990CI-TRIAL-00034465completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entrectinib | Drug | Entrectinib | ALIAS |
| Midazolam Hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Entrectinib / Midazolam
- interventionNames
- Drug: Entrectinib
- Drug: Midazolam Hydrochloride
Primary outcomes (5)
- measure
- AUClast
- timeFrame
- 4 weeks
- description
- 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.
- measure
- AUCinf
- timeFrame
- 4 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.