Clinical Trial: Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome

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

Official Title: Extension Protocol of BMS-833923 in Subjects With Basal Cell Nevus Syndrome

Brief Summary: This is an extension study of Protocol CA194002 to allow 2 specific participants with basal cell nevus syndrome in the CA194002 study at Princess Margaret Cancer Centre who are still benefitting from the study drug BMS-833923 to continue receiving the study drug. This study will continue to evaluate the safety and tolerability of BMS-833923 in these participants.

Detailed Summary: The purpose of this study is to evaluate the safety and tolerability of BMS-833923 administered on an extension protocol in subjects with basal cell nevus syndrome (BCNS). This is an extension study of Protocol CA194002 to allow 2 specific participants with BCNS in the CA194002 study at Princess Margaret Cancer Centre who are still benefitting from the study drug BMS-833923, to continue receiving the study drug. In this open-label extension protocol, no new subjects will be recruited. The two BCNS subjects from Protocol CA194002 (subjects CA194002-1-14 and CA194002-1-25) will continue to receive BMS-833923 at the dose and schedule administered on CA194002 until fulfilling protocol criteria for discontinuation. These patients are receiving different doses: one being 60mg once every 2 weeks, and the other is receiving 300mg once daily. This study will continue to evaluate the safety and tolerability of BMS-833923 in these participants.
Sponsor: University Health Network, Toronto

Current Primary Outcome: Frequency of side effects experienced per participant [ Time Frame: From date of first study drug dose taken for this study until participant discontinuation, assessed up to 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Length of time participants' disease does not worsen [ Time Frame: From date of first study drug dose taken for this study until the date of first documented progression or date of death from any cause, whichever comes first, accessed up to 5 years ]

Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: February 28, 2014
Date Started: February 2014
Date Completion: August 2019
Last Updated: July 8, 2015
Last Verified: July 2015