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

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.

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