Clinical Trial: Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2b Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Oral HBI-8000 in Patients With Relapsed or Refractory Adult T Cell Lymphoma (ATL)
Brief Summary: Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL)
Detailed Summary: This is a Phase 2b, open-label, non-randomized, single arm study to evaluate the safety, and efficacy of HBI-8000 40 mg BIW in patients with relapsed or refractory ATL (R/R ATL). HBI 8000 will be administered orally approximately 30 minutes after any regular meal twice a week. There will be 3 to 4 days between dosing. A treatment cycle is defined as 28 consecutive days. HBI-8000 administration will be continued until disease progression or unacceptable toxicities are observed despite appropriate dose reduction or treatment interruption.
Sponsor: HUYA Bioscience International
Current Primary Outcome: Objective Response Rate [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 18 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective Response Rate by disease subtype [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 18 months ]
- Median duration of progression-free survival (PFS) [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 18 months ]
- Median duration of response (DOR) [ Time Frame: Until disease progression or unacceptable toxicity, assessed up to 18 months ]
Original Secondary Outcome: Same as current
Information By: HUYA Bioscience International
Dates:
Date Received: November 1, 2016
Date Started: November 2016
Date Completion: December 2019
Last Updated: April 30, 2017
Last Verified: April 2017
