NCT00355472

Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL

Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).

Detailed description

This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.

Conditions

• Adult T-Cell Leukemia and Lymphoma (ATL)
• Adult Peripheral T-Cell Lymphoma (PTCL)

Interventions

Type	Name	Description
DRUG	KW-0761	IV administration at 4 escalating dose levels.

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2006-07-24
• Last updated: 2012-10-18
• Results posted: 2012-09-07

Locations

1 site across 1 country: Japan