A Study of TAK-441 in Adult Patients With Advanced Nonhematologic Malignancies

Millennium Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Basal Cell; Advanced Nonhematologic Malignancies

Treatments: Drug: TAK-441

Study type: Interventional

Funder types: Industry

Identifiers

NCT01204073

C24002

2010-021311-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

TAK-441

Experimental group

Treatment:

Drug: TAK-441