- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01204073
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
A Multicenter, Open-Label, Dose-Escalation, Phase 1 Study of TAK-441, an Oral Hedgehog Signaling Pathway Inhibitor, in Adult Patients With Advanced Nonhematologic Malignancies
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic
-
-
California
-
Santa Monica, California, United States, 90404
- Premiere Oncology, A Medical Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 exclusion criteria are not to be enrolled in the study:
- Life-threatening illness unrelated to cancer
- Receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of TAK-441
- Patients with brain metastases who do not meet criteria specified in study protocol
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
- Major surgery within 14 days before the first dose of TAK-441
- Infection requiring systemic therapy, or other serious infection within 14 days of the first dose of TAK-441
- Do not meet other clinical, laboratory or radiographic criteria as specified in the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TAK-441
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 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
|
From first dose of TAK-441 through 30 days after the last dose of TAK-441
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single-dose and multiple-dose plasma pharmacokinetics (PK) of TAK-441
Time Frame: 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)
|
Sampling during Cycle 1 (Days 1-28)
|
Pharmacodynamic effect of TAK-441 on Gli 1 expression in skin
Time Frame: Cycle 1 Day 22
|
Cycle 1 Day 22
|
|
Pharmacodynamic effect of TAK-441 on Gli 1 expression in tumors (expansion cohorts only)
Time Frame: Cycle 1 Day 15
|
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
Time Frame: 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)
|
Days 15-21 of cycles 2, 4 and every fourth cycle thereafter; and end of study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C24002
- 2010-021311-17 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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