A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas (BCCs).
- Conditions
- Adult patients with multiple basal cell carcinomas (BCCs).MedDRA version: 14.1Level: PTClassification code 10004146Term: Basal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003305-10-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 229
- Written, signed informed consent, including consent for photographs of target lesions (required) and non-target lesions (optional)
- Age = 18 years
- Have multiple BCCs, including patients with Gorlin syndrome, with significant burden of skin disease as manifested by at least 6 clinically evident BCCs at the time of randomization, at least three of which measure 5 mm or more in diameter (target lesions)
- Histopathologic confirmation that at least one of the three target lesions is BCC before randomization (2 mm punch biopsy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate hematopoietic capacity, hepatic and renal function
- For women of childbearing potential a negative pregnancy test within 7 days prior to commencement of dosing is required
- Women of child-bearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least 7 months after completion of study treatment.
- For male patients with female partners of childbearing potential, agreement to use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with vismodegib/placebo, and for 2 months after completion of study treatment
- Agreement not to donate blood or blood products during the study and for at least 7 months after completion of study treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- Inability or unwillingness to swallow capsules and to comply with study procedures
- Pregnancy or breastfeeding
- Any metastatic BCC
- Locally advanced BCC lesion that is considered to be inoperable or to have a medical contraindication to surgery in the opinion of a Mohs surgeon, dermatologic surgeon, head and neck surgeon, surgical oncologist, or plastic surgeon.
- Recent (i.e., within the past 28 days prior to randomization) or current participation in another experimental drug study
- Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
- Any medical or psychological illness or condition preventing adequate consent or ability to comply with the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the relative reduction from baseline (%) in the number of clinically evident BCCs at a defined time point in two different vismodegib regiments.;Secondary Objective: - drop-out rate <br>- relative reduction from baseline in total size of BCCs<br>- recurrence rate<br>- safety <br>- patient reported outcomes;Primary end point(s): Relative reduction from baseline (%) in the number of clinically evident BCCs at a defined time point in two different vismodegib regiments;Timepoint(s) of evaluation of this end point: Week 73
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Drop-out rate, relative reduction from baseline in total size of BCCs, recurrence rate, safety, patient reported outcomes;Timepoint(s) of evaluation of this end point: Treatment Phase (Week 9, 17, 25, 33, 41, 49, 57 and 65), Week 73, 85, 97 and 125