NCT01179399

Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies

A Phase 1, Open-Label, Dose-Escalation Study of Orally Administered TAK-960, a Polo-Like Kinase 1 Inhibitor, in Patients With Advanced Nonhematologic Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Overview of Study Design: This is a phase 1, multicenter, open-label, multiple-dose, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of TAK-960 in patients with advanced nonhematologic malignancies. This study will be the first to administer TAK-960 to humans. The patient population will consist of adults with a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential, or for which no standard treatment is available.

Conditions

• Advanced Nonhematological Malignancies

Interventions

Type	Name	Description
DRUG	TAK-960	TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2010-08-11
• Last updated: 2014-03-03
• Results posted: 2014-03-03

Locations

2 sites across 1 country: United States