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

NCT ID: NCT02100371

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-05-31

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.

Conditions

Basal Cell Nevus Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BMS-833923

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

Group Type: EXPERIMENTAL

BMS-833923

Intervention Type: DRUG

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

Interventions

BMS-833923

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

Intervention Type: DRUG

Other Intervention Names

XL139

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lillian Siu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CA194-103

Identifier Type: -

Identifier Source: org_study_id