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