International study assessing two different vismodegib regiments in people with multiple basal cell carcinomas.
- Conditions
- Adult patients with multiple basal cell carcinomas (BCCs).MedDRA version: 17.1Level: 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-DE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
- 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, of which three measure 5 mm
or more in diameter and are considered target lesions. All other lesions
are considered to be non-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 serum 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
24 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
- For male patients, agreement not to donate sperm during treatment
and for at least 2 months after discontinuation of 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
- Known or suspected alcohol abuse in the opinion of the investigator
- Patients with one of the following known rare hereditary conditions:
galactose intolerance, primary hypolactasia or glucose-galactose
malabsorption
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