Overview

This trial is active, not recruiting.

Condition basal cell nevus syndrome
Treatment bms-833923
Sponsor University Health Network, Toronto
Start date February 2014
End date February 2019
Trial size 2 participants
Trial identifier NCT02100371, CA194-103

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.
bms-833923 XL139
BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Extension Protocol of BMS-833923 in Subjects With Basal Cell Nevus Syndrome
Principal investigator Lillian Siu, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.