Basal Cell CarcinomasPhase 2NCT02067104
Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention
A Phase 2 study testing Vismodegib in people with Basal Cell Carcinomas, run by University of Arizona at 1 site in United States.
Trial summary
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinomas
- What is being tested?
- Vismodegib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2014to 31 Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects
- Comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- At least 18 years of age at the time of informed consent.
- History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2 years prior to the screening visit.
- No active skin cancers.
- Women of reproductive potential must agree to use two forms of acceptable contraception
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- Male subjects must agree to use condoms at all times, even after a vasectomy, during sexual intercourse with female partners of reproductive potential during treatment with vismodegib and for 2 months after the last dose to avoid exposing a pregnant partner and the unborn fetus to vismodegib.
- Male patients must agree not to donate sperm during the study and for 2 months after discontinuation of vismodegib
- Agreement not to donate blood or blood products during the study and for 7 months after the last dose.
- Ability to understand and the willingness to sign a written informed consent document in English
Who cannot join
- Women who are pregnant or lactating, or planning pregnancy while enrolled in the study or for 7 months after the last dose of the study drug.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects with clinically stable chronic medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.
- Inability or unwillingness to swallow capsules.
- Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed.
- Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
- Currently receiving vismodegib, biologics or chemotherapy
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- Currently undergoing treatment with photodynamic therapy, topical chemotherapy agents including Imiquimod, fluorouracil
- Subjects who have Gorlins syndrome
- Subjects who have received any type of solid organ transplant
- Subjects taking immunosuppressive medications at the screening visit. (Day 0)
- Participation in other study using an investigational or experimental therapy or procedure within 4 weeks or 5 half-lives (whichever is longer) before the screening visit and/or during study participation. Subjects cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Subjects unable or unwilling to comply with the study visit schedule and requirements of the study
- Subjects unable to speak and read the English language
- A subject who, in the opinion of the sponsor-investigator will be uncooperative or unable to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Placebo Controlled Double-Blind Study to Evaluate the Efficacy of Vismodegib as Chemoprevention of New Bcc Development in High Risk Subjects
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).
Read the detailed description
The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period.
The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.
- Conditions
- Basal Cell Carcinomas
- Being tested
- Vismodegib, Placebo
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VismodegibDrug
Also called Erivedge
Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
PlaceboDrug
Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | receive 150 mg of oral placebo daily for a period of 2 months Receives: Drug: Placebo |
| Vismodegib | Experimental | receive 150 mg of vismodegib daily for a period of 2 months Receives: Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Vismodegib Pulse Therapy on the Incidence of Newly Diagnosed Basal Cell Carcinomas (BCC)
Measured by the incidence of biopsy confirmed BCC over a 24 month period
Measured: 24 Months
Secondary outcomes (1)
The Incidence of Newly Diagnosed Squamous Cell Carcinomas (SCC) in the Same Subjects Receiving Vismodegib Treatment When Compared With Placebo
Measured by the incidence of biopsy confirmed SCC over the same 24 month period
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start17 Feb 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basal Cell CarcinomasStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clara Curiel-Lewandroski, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067104
- Sponsor's protocol ID
- 1401183410
- Other IDs
- ML28585
- Status last verified
- Jul 2019
- First submitted
- 18 Feb 2014
- Last updated
- 14 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Double-Blind Study to Evaluate the Efficacy of Vismodegib as Chemoprevention of New Bcc Development in High Risk Subjects
- ClinicalTrials.gov ID
- NCT02067104
- Acronym / sponsor ID
- 1401183410
- Conditions
- Basal Cell Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 17 Feb 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Posted 31 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).
Detailed description
The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period.
The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placeboreceive 150 mg of oral placebo daily for a period of 2 months |
| Vismodegib | Experimental | Drug: Vismodegibreceive 150 mg of vismodegib daily for a period of 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects
- Comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- At least 18 years of age at the time of informed consent.
- History of 3 or more biopsy confirmed BCCs in the preceding 2 years, calculated from 2 years prior to the screening visit.
- No active skin cancers.
Key exclusion criteria (15 listed)
- Women who are pregnant or lactating, or planning pregnancy while enrolled in the study or for 7 months after the last dose of the study drug.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Subjects with clinically stable chronic medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis, will be allowed to enter the study.
- Inability or unwillingness to swallow capsules.
- Have a history of alcohol of substance abuse, unless in full remission for greater than 6 months prior to the screening visit (Day 0) when the consent form is signed.
- Known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C viruses.
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 |
|---|---|---|
| VismodegibAlso: ErivedgePulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months. | Drug | Vismodegib |
| PlaceboPulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months. | Drug | Placebo |
Primary outcome
The Effect of Vismodegib Pulse Therapy on the Incidence of Newly Diagnosed Basal Cell Carcinomas (BCC)
Time frame: 24 Months
Measured by the incidence of biopsy confirmed BCC over a 24 month period
1 secondary outcome
The Incidence of Newly Diagnosed Squamous Cell Carcinomas (SCC) in the Same Subjects Receiving Vismodegib Treatment When Compared With Placebo
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clara Curiel-Lewandroski principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vismodegib in people with Basal Cell Carcinomas, run by University of Arizona at 1 site in United States.
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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Aug 2019. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effect of Vismodegib Pulse Therapy on the Incidence of Newly Diagnosed Basal Cell Carcinomas (BCC) (time frame: 24 Months). 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 14 Aug 2019.