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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02100371

Collaborator

(none)

Enrollment

Location

Arm

38.9

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Nevus Syndrome	Drug: BMS-833923	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-833923 BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.	Drug: BMS-833923 BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002. Other Names: XL139

Arm

Intervention/Treatment

Experimental: BMS-833923

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

Drug: BMS-833923

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

Other Names:

XL139

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Length of time participants' disease does not worsen [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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