Basal Cell Nevus SyndromeNCT02100371
Study of BMS-833923 in Two Specific Patients With Basal Cell Nevus Syndrome
A study testing BMS-833923 in people with Basal Cell Nevus Syndrome, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Basal Cell Nevus Syndrome
- What is being tested?
- BMS-833923
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Basal Cell Nevus Syndrome
- Being tested
- BMS-833923
- Keywords
- BMS-833923, CA194002
- Medical subject headings
- Basal Cell Nevus Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-833923Drug
Also called XL139
BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.
| Study group | Role | What they receive |
|---|---|---|
| BMS-833923 | Experimental | BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002. Receives: Drug: BMS-833923 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of side effects experienced per participant
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell Nevus SyndromeStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lillian Siu, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100371
- Sponsor's protocol ID
- CA194-103
- Status last verified
- Jul 2017
- First submitted
- 28 Feb 2014
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension Protocol of BMS-833923 in Subjects With Basal Cell Nevus Syndrome
- ClinicalTrials.gov ID
- NCT02100371
- Acronym / sponsor ID
- CA194-103
- Conditions
- Basal Cell Nevus Syndrome
- Keywords
- BMS-833923, CA194002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-833923 | Experimental | Drug: BMS-833923BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-833923Also: XL139BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002. | Drug | BMS-833923 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lillian Siu, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMS-833923 in people with Basal Cell Nevus Syndrome, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.