Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| GO40785 | Other Identifier | Hoffman-La Roche |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entrectinib / Midazolam | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entrectinib | Drug | 600 mg oral capsule (fasted and fed) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | 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. | 4 weeks |
| AUCinf | 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. | 4 weeks |
| Cmax | Peak plasma concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib. | 4 weeks |
| Tmax | Time of maximum concentration of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib. | 4 weeks |
| t1/2 | Terminal half-life of midazolam and the pharmacologically active metabolite 1-hydoxymidazolam in the absence or presence of entrectinib. | 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Patients must meet the following criteria in order to be included in the research study:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCRI-Denver Drug Development Program | Denver | Colorado | 80218 | United States | ||
| Florida Cancer Specialists - Sarasota (North Catttlemen Rd) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000607349 | entrectinib |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
All patients entering this study will receive midazolam and entrectinib.
Not provided
Not provided
Not provided
Not provided
| Midazolam Hydrochloride |
| Drug |
2 mg oral syrup (fasted) |
|
| Sarasota |
| Florida |
| 34232 |
| United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| D006571 | Heterocyclic Compounds |