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

University Health Network, Toronto

Status

Completed

Conditions

Basal Cell Nevus Syndrome

Treatments

Drug: BMS-833923

Study type

Interventional

Funder types

Other

Identifiers

NCT02100371

CA194-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed consent
Two specific study participants enrolled on protocol CA194002 at Princess Margaret Cancer Centre and remain on BMS-833923 at the time of study entry
Women, age 18 years and above
Agree to use methods to prevent pregnancy, not pregnant or breastfeeding

Exclusion criteria

Known symptomatic brain metastasis
A serious uncontrolled medical disorder or active infection, which would impair the ability of the patient to receive protocol therapy
Gastrointestinal disease or surgery that could impact the absorption of study drug
Inability to swallow oral medication
Inability to be venipunctured and/or tolerate venous access
Uncontrolled or significant cardiovascular
Any other medical, psychiatric and/or social reason
Have HIV, HepB, or HepC
Exposure to immunosuppressants and immunotherapy concurrently with study treatment and up to 3 months
Acceptable physical and laboratory test findings
History of allergy to compounds chemically-related