Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02100371
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Basal Cell Nevus Syndrome Drug: BMS-833923 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extension Protocol of BMS-833923 in Subjects With Basal Cell Nevus Syndrome
Study Start Date : February 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


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 Name: XL139




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100371


Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Lillian Siu, M.D. Princess Margaret Cancer Centre

Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02100371     History of Changes
Other Study ID Numbers: CA194-103
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by University Health Network, Toronto:
BMS-833923
CA194002

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Nevus
Nevus, Pigmented
Basal Cell Nevus Syndrome
Disease
Pathologic Processes
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Carcinoma, Basal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Basal Cell
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn