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

July 7, 2017 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From date of first study drug dose taken for this study until participant discontinuation, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Lillian Siu, M.D., Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA194-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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