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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021311-17 | EudraCT Number |
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This is the first study in which TAK-441 is administered to humans. The patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. Following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-441 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-441 | Drug | TAK-441 will be administered as an oral tablet as follows: Patients enrolled in the dose escalation cohorts will receive:
Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile, maximum tolerated dose (MTD) or maximum feasible dose (MFD) of TAK-441 administered as an oral formulation in patients wtih advanced nonhematologic malignancies | Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements | From first dose of TAK-441 through 30 days after the last dose of TAK-441 |
| Measure | Description | Time Frame |
|---|---|---|
| Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441 | Including but not limited to maximum plasma concentration (Cmax), first time to plasma concentration (Tmax) and area under the plasma concentration versus time curve (AUC) | Sampling during Cycle 1 (Days 1-28) |
| Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin |
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Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259-5499 | United States | ||
| Premiere Oncology, A Medical Corporation |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C577980 | TAK-441 |
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|
| Cycle 1 Day 22 |
| Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only) | Cycle 1 Day 15 |
| Antitumor activity of TAK-441 administered as a single-agent therapy based on investigators' assessments of tumor response in patients who have advanced basal cell carcinoma | Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) | Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study |
| Santa Monica |
| California |
| 90404 |
| United States |
| D018295 |
| Neoplasms, Basal Cell |