Clinical Trial: PNT2258 for Treatment of Patients With Richter's Transformation (Brighton)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Study of PNT2258 in Patients With Richter's Transformation (RT)
Brief Summary: This study is sponsored by Sierra Oncology, Inc. formerly ProNAi Therapeutics, Inc. It is a multi-center, single-arm, 2-stage, open-label phase II investigation of PNT2258 to characterize anti-tumor activity and collect safety data on patients with Richter's Transformation.
Detailed Summary:
Sponsor: Sierra Oncology, Inc.
Current Primary Outcome: Overall Response Rate [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Disease control rate [ Time Frame: 6 months ]
- Duration of overall response [ Time Frame: 24 months ]
- Time to response [ Time Frame: 6 months ]
- Progression free survival [ Time Frame: 24 months ]
- Overall survival [ Time Frame: 24 months ]
- Safety [ Time Frame: 24 months ]Safety will be assessed by standard CTCAE criteria
Original Secondary Outcome:
Information By: Sierra Oncology, Inc.
Dates:
Date Received: February 26, 2015
Date Started: August 2015
Date Completion:
Last Updated: January 20, 2017
Last Verified: January 2017