Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome
Primary Purpose
Basal Cell Nevus Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BMS-833923
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Nevus Syndrome focused on measuring BMS-833923, CA194002
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
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS-833923
Arm Description
BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.
Outcomes
Primary Outcome Measures
Frequency of side effects experienced per participant
Secondary Outcome Measures
Length of time participants' disease does not worsen
Full Information
NCT ID
NCT02100371
First Posted
February 28, 2014
Last Updated
July 7, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02100371
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 Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Nevus Syndrome
Keywords
BMS-833923, CA194002
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-833923
Arm Type
Experimental
Arm Description
BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.
Intervention Type
Drug
Intervention Name(s)
BMS-833923
Other Intervention Name(s)
XL139
Intervention Description
BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lillian Siu, M.D.
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
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Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome
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