Study of BMS-833923 in Two Specific Patients With Basal C... | NCT02100371

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

NCT02100371

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Jul 11, 2017Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Basal Cell Nevus Syndrome

Interventions

BMS-833923

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Feb 28, 2014

First Submission Date that Met QC Criteria

Mar 26, 2014

First Posted Date

Mar 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2017

Last Update Posted Date

Jul 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BMS-833923	Experimental	BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.	Drug: BMS-833923

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BMS-833923	Drug	BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.	BMS-833923

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lillian Siu, M.D.	Princess Margaret Cancer Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Princess Margaret Cancer Centre		Toronto	Ontario	M5G 2M9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001478	Basal Cell Nevus Syndrome

Ancestor Terms

ID	Term
D009807	Odontogenic Cysts
D007570	Jaw Cysts
D001845	Bone Cysts
D003560	Cysts
D009369

Browse Leaves

Not provided

Browse Branches

Not provided