Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell
Conditions
Brief summary
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.
Interventions
DRUGTAK-441
TAK-441 will be administered as an oral tablet as follows: Patients enrolled in the dose escalation cohorts will receive: * A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed * Continuous daily dosing on Days 8 through 28 in Cycle 1 * In subsequent cycles, continuous daily dosing over 21 days, repeated continuously Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Male or female 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 * Diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential * Meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol * Voluntary written consent
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From first dose of TAK-441 through 30 days after the last dose of TAK-441 | Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441 | Sampling during Cycle 1 (Days 1-28) | 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) |
| Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin | 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 | Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study | Based on the investigator's assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) |
Countries
United States
Outcome results
None listed