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Spots Global Cancer Trial Database for Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome

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Trial Identification

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

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

Study ID: NCT02100371

Interventions

BMS-833923

Study Description

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 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Contact Details

Name: Lillian Siu, M.D.

Affiliation: Princess Margaret Cancer Centre

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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