NCT02100371

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Basal Cell Nevus Syndrome

Interventions

Type	Name	Description
DRUG	BMS-833923	BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2014-03-31
• Last updated: 2017-07-11

Locations

1 site across 1 country: Canada