Basal Cell CarcinomaPhase 2NCT01898598
A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
A Phase 2 study testing Vismodegib in people with Basal Cell Carcinoma, run by Hoffmann-La Roche at 21 sites in United States.
Trial summary
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- 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
- 18 participants
- Where
- 21 sitesUnited States
- Study dates
- 23 Jan 2014to 26 Jan 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
- Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
- Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
- Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
Who cannot join
- Prior treatment with vismodegib
- Known hypersensitivity to any of the study drug excipients
- Any metastatic basal cell carcinoma
- Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
- Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
- Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
- Recent, current, or planned participation in another experimental drug study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Moy-Fincher-Chipps Facial Plastics and Dermatology
Beverly Hills, California, 90210
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Northwestern University
Chicago, Illinois, 60611
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030-4095
Scripps Clinic
La Jolla, California, 92037
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Wisconsin
Madison, Wisconsin, 53792
University of Minnesota
Minneapolis, Minnesota, 55455
Beth Israel Cancer Center; West Campus
New York, New York, 10011
Stanford University
Palo Alto, California, 94305
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Oregon Health & Science University; Department of Dermatology
Portland, Oregon, 97239-4501
University of Rochester Medical Center; University Dermatology Associates
Rochester, New York, 14642
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, 84112
California Pacific Medical Center
San Francisco, California, 94107
Univ of Calif-San Francisco
San Francisco, California, 94115
Mayo Clinic
Scottsdale, Arizona, 85259
Spencer Derma & Skin Surg Ctr
St. Petersburg, Florida, 33716
Mariwalla Dermatology
West Islip, New York, 11795
The Skin Surgery Center
Winston-Salem, North Carolina, 27106
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
- Conditions
- Basal Cell Carcinoma
- Being tested
- Placebo, Vismodegib
- 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.
PlaceboDrug
Participants will receive matching placebo to vismodegib for 12 weeks.
VismodegibDrug
Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks. Receives: Drug: Placebo |
| Vismodegib | Experimental | Participants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks. Receives: Drug: Vismodegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
The percent change in target BCC expected surgical defect area was defined as ([baseline expected surgical defect area - expected surgical defect area at MMS visit]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.
Measured: Baseline, MMS visit (Week 12-14)
Secondary outcomes (5)
Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
Actual change was defined as (baseline expected surgical defect area - expected surgical defect area at MMS visit). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment. Expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry).
Measured: Baseline, MSS Visit (Week 12-14)
Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit
Percent change in target BCC actual tumor-free margin excision area was defined as = (expected surgical defect area pre-treatment - actual tumor-free margin excision area at MMS visit) / expected surgical defect area pre-treatment) * 100%. The actual tumor-free margin excision area (includes 2 millimeters [mm] margin) was measured during MMS. The area was photographed and traced on the digital photograph then calculated by computer-aided planimetry. MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.
Measured: Baseline, MMS visit (Week 12-14)
Percentage of Participants With Clinical Response
Clinical response was defined as a complete response (CR) or partial response (PR) at the post-treatment MMS excision. CR was defined as no histological evidence of BCC. PR was defined as a reduction of at least 50 % in the expected surgical defect area with histologic evidence of residual BCC. MMS visit was defined the visit that occurred within 2 weeks of the last study treatment.
Measured: MMS visit (Week 12-14)
Percentage of Participants With Skip Area
Skip area was defined as the presence of non-contiguous residual tumor at the MMS visit, as determined by an independent dermatopathologist. MMS visit occurred within 2 weeks of the last study treatment.
Measured: MMS visit (Week 12-14)
Percentage of Participants With BCC Recurrence
Measured: Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study start23 Jan 2014
- Primary completion26 Jan 2016
- Study completion26 Jan 2016
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898598
- Sponsor's protocol ID
- ML28726
- Status last verified
- Mar 2017
- First submitted
- 3 Jul 2013
- Last updated
- 8 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Oral Vismodegib for the Treatment of Basal Cell Carcinoma Preceding Excision by Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT01898598
- Acronym / sponsor ID
- ML28726
- Conditions
- Basal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2014 (actual)
- Primary completion
- 26 Jan 2016 (actual)
- Study completion
- 26 Jan 2016 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 8 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo to vismodegib capsule orally once daily for 12 weeks. |
| Vismodegib | Experimental | Drug: VismodegibParticipants will receive vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
- Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
- Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements
Key exclusion criteria (7 listed)
- Prior treatment with vismodegib
- Known hypersensitivity to any of the study drug excipients
- Any metastatic basal cell carcinoma
- Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
- Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
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 |
|---|---|---|
| PlaceboParticipants will receive matching placebo to vismodegib for 12 weeks. | Drug | Placebo |
| VismodegibParticipants will receive vismodegib 150 mg oral capsule once a day for 12 weeks | Drug | Vismodegib |
Primary outcome
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit
Time frame: Baseline, MMS visit (Week 12-14)
The percent change in target BCC expected surgical defect area was defined as ([baseline expected surgical defect area - expected surgical defect area at MMS visit]/ baseline expected surgical defect area) × 100 percent (%) where expected surgical defect area was manually outlined on a digital photograph and measured by a computer (computer aided planimetry). MMS visit was defined as the visit that occurred within 2 weeks of the last study treatment.
5 secondary outcomes
Actual Change in Target BCC Expected Surgical Defect Area at MMS Visit
Time frame: Baseline, MSS Visit (Week 12-14)
Percentage Change in Target BCC Actual Tumor-Free Margin Excision Area at MMS Visit
Time frame: Baseline, MMS visit (Week 12-14)
Percentage of Participants With Clinical Response
Time frame: MMS visit (Week 12-14)
Percentage of Participants With Skip Area
Time frame: MMS visit (Week 12-14)
Percentage of Participants With BCC Recurrence
Time frame: Baseline, 12, 24, and 52 weeks post MMS Visit (MMS Visit = Week 12-14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
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.
Clinical Trials study director
Hoffmann-La Roche
21 sites 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 Carcinoma, run by Hoffmann-La Roche at 21 sites 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 3 inclusion and 7 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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 8 May 2017). 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?
Percent Change in Target Basal Cell Carcinoma (BCC) Expected Surgical Defect Area at Mohs Micrographic Surgery (MMS) Visit (time frame: Baseline, MMS visit (Week 12-14)). 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 8 May 2017.