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

Ovarian Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02661815
Study type Interventional
Source Dana-Farber Cancer Institute
Contact
Status Terminated
Phase Phase 1
Start date June 15, 2016
Completion date July 28, 2017
View Details
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