Clinical Trial: Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma
Brief Summary: The purpose of this study is to evaluate the efficacy of KW-0761 intravenously administered eight times at one-week intervals in patients with CCR4-positive peripheral T/NK-cell lymphoma. The primary objective is to assess the antitumor effect in terms of best overall response, while the secondary objectives are to assess the antitumor effect in terms of best response by disease lesion, to assess the progression-free survival and to assess the overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also evaluated.
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd
Current Primary Outcome: Antitumor effect (best overall response)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Antitumor effect (best response by disease lesion), progression-free survival and overall survival
- Adverse events and anti-KW-0761 antibody levels
- Plasma KW-0761 concentrations and pharmacokinetic parameters
Original Secondary Outcome: Same as current
Information By: Kyowa Hakko Kirin Co., Ltd
Dates:
Date Received: August 30, 2010
Date Started: September 2010
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017
