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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Advanced Nonhematologic Malignancies
• Carcinoma, Basal Cell

Interventions

Type	Name	Description
DRUG	TAK-441	TAK-441 will be administered as an oral tablet as follows: Patients enrolled in the dose escalation cohorts will receive: * A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed * Continuous daily dosing on Days 8 through 28 in Cycle 1 * In subsequent cycles, continuous daily dosing over 21 days, repeated continuously Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-12-01
• Completion: 2013-01-01
• First posted: 2010-09-17
• Last updated: 2013-07-02

Locations

2 sites across 1 country: United States