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
18 Years
N/A
Both
Advanced Nonhematologic Malignancies, Carcinoma, Basal Cell
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Description:
Adverse events, serious adverse events, dose-limiting toxicities, assessments of clinical laboratory values, electrocardiogram parameters and vital sign measurements
Outcome Time Frame:
From first dose of TAK-441 through 30 days after the last dose of TAK-441
Safety Issue:
Yes
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Millennium Pharmaceuticals, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
C24002
NCT ID:
NCT01204073
Start Date:
October 2010
Completion Date:
January 2013
Related Keywords:
- Advanced Nonhematologic Malignancies
- Carcinoma, Basal Cell
- Neoplasms
- Carcinoma
- Carcinoma, Basal Cell
Name | Location |
|---|---|
| Mayo Clinic | Scottsdale, Arizona |
| Premiere Oncology, A Medical Corporation | Santa Monica, California 90404 |
