NCT00831896

Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematological Malignancies

A Multicenter, Open-Label, Dose Escalation Phase I Study of TAK-701 in Adult Patients With Advanced Nonhematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, dose escalation, phase 1 study of TAK 701 in adult patients with advanced nonhematologic malignancies. This study will be the first to administer TAK 701 to humans. The primary purpose of this study is to determine the safety profile, tolerability, and pharmacokinetics profile of TAK-701.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	TAK-701	Either 2, 5, 10, or 20 mg/kg IV. Cycle 1: single dose at 2x the dose assignment; Cycle 2 and beyond: dose once every two weeks Dosing continues until disease progression, unacceptable toxicity related to TAK-701, or maximum of 12 cycles, unless determined that patient would benefit from continued therapy.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-11-01
• Completion: 2011-05-01
• First posted: 2009-01-29
• Last updated: 2011-12-02

Locations

3 sites across 1 country: United States