Clinical Trial: A Study for Patients With Relapsed Cutaneous T-Cell Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Open-Label, Multicenter Study of Single-Agent Enzastaurin in Patients With Relapsed Cutaneous T-Cell Lymphoma
Brief Summary: The purpose of the study is to determine the efficacy and safety of enzastaurin in patients with CTCL who failed prior therapies.
Detailed Summary:
Sponsor: Eli Lilly and Company
Current Primary Outcome: Response Rate [ Time Frame: baseline to measured progressive disease ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response for responding patients [ Time Frame: time of response to progressive disease ]
- Time to progression [ Time Frame: baseline to measured progressive disease ]
- Time to objective response for responding patients [ Time Frame: baseline to confirmed response ]
- Patient-reported measures of health-state utility and pruritus [ Time Frame: every cycle ]
- Safety and tolerability of enzastaurin in this patient population [ Time Frame: every cycle ]
Original Secondary Outcome: Same as current
Information By: Eli Lilly and Company
Dates:
Date Received: August 29, 2008
Date Started: September 2008
Date Completion:
Last Updated: October 25, 2010
Last Verified: October 2010
