Clinical Trial: A Phase 1b Study of Paclitaxel And Ricolinostat For The Treatment Of Gynecological Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 1b Study of Weekly Paclitaxel And Oral Ricolinostat For The Treatment Of Recurrent Platinum Resistant Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer

Brief Summary: Participants with Ovarian, Fallopian Tube, or Peritoneal Cancer that has recurred within 12 months of prior treatment that includes Platinum Chemotherapy are invited to take part in this study. This research study is studying a combination of a new chemotherapy drug called Ricolinostat together with the chemotherapy Paclitaxel and a drug called Bevacizumab as a possible treatment for this diagnosis.

Detailed Summary:

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies.

The FDA (the U.S. Food and Drug Administration) has not approved Ricolinostat as a treatment for any disease. The FDA has approved Paclitaxel as a treatment option for Ovarian, Fallopian Tube, or Peritoneal Cancer . The FDA has approved Bevacizumab in combination with chemotherapy as a treatment option for Ovarian, Fallopian Tube, or Peritoneal Cancer .

In this study, we are hoping to learn what is the highest dose of Ricolinostat that can be given safely together with Paclitaxel on a weekly basis or with Paclitaxel on a weekly basis and Bevacizumab every other week. Ricolinostat is a drug that stops cancer from growing by blocking the action of a protein called HDAC.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Analysis Report on the MTD In The Dose Escalation Portion Of The Study [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Peripheral Neurotoxicity Assessed Using TNS by Measuring 5 Categories [ Time Frame: 2 years ]
  • Best Overall Response Measured From, Start Of Treatment To The End [ Time Frame: 2 years ]
  • Duration Of Overall Response, Measured From The Time Measurement Criteria Are Met For PR or CR Until The First Date Recurrent Or Progressive Disease Is Objectively Documented. [ Time Frame: 2 years ]
  • Progression-free survival (PFS) [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: January 20, 2016
Date Started: January 2016
Date Completion: January 2022
Last Updated: February 27, 2017
Last Verified: February 2017