Status:
COMPLETED
A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Nonhematologic Malignancies
Carcinoma, Basal Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01204073
Start Date
October 1 2010
End Date
January 1 2013
Last Update
July 2 2013
Active Locations (2)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5499
2
Premiere Oncology, A Medical Corporation
Santa Monica, California, United States, 90404