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

NCT02100371 | Completed

• 1 other identifier: CA194-103
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Basal Cell Nevus Syndrome

Keywords

BMS-833923; CA194002

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

BMS-833923

EXPERIMENTAL

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

Drug: BMS-833923

Interventions

BMS-833923 DRUG

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

Also known as: XL139

BMS-833923

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Basal Cell Nevus Syndrome

Interventions

BMS-833923

Condition Hierarchy (Ancestors)

Odontogenic Cysts; Jaw Cysts; Bone Cysts; Cysts; Neoplasms; Carcinoma, Basal Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Basal Cell; Neoplastic Syndromes, Hereditary; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Lillian Siu, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2014
• First Posted: March 31, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

CA (1)