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

Basal Cell Nevus Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100371
• Other study ID #: CA194-103
• Status: Completed
• Phase: N/A
• First received: February 28, 2014
• Last updated: July 7, 2017
• Start date: February 2014
• Est. completion date: May 2017

Study information

• Verified date: July 2017
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Nevus Syndrome
• Nevus
• Nevus, Pigmented
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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