A PHASE II, SINGLE-ARMED, MULTICENTER TRIAL OF NEOADJUVANT VISMODEGIB IN PATIENTS WITH LARGE AND/OR RECURRENT RESECTABLE BASAL CELL CARCINOMA - NICCI
- Conditions
- Patients with large and/or recurrent resectable basal cell carcinomaMedDRA version: 20.0Level: 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
- EUCTR2016-002856-26-DE
- Lead Sponsor
- SRH Wald-Klinikum Gera GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1.Male or female patient aged = 18 years
2.Able to participate and willing to give written informed consent including consent for photographs prior to performance of study-related procedures and to comply with the study protocol.
3.Patients with at least 1 large (= 2 cm in diameter in head/neck region, = 5 cm for trunk/extremities) basal cell carcinoma (BCC), still resectable, but with increased risk for cosmetic disfigurement or functional defects by assessment of the enrolling physician. Patients with large (as defined above) recurrent basal cell carcinoma are also eligible.
4.Patients must be naïve to treatment with vismodegib or other hedgehog pathway inhibitors
5.Local histopathologic confirmation of BCC (3 mm punch biopsy)
6.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
7.Consent to undergo mapping biopsies upon reaching complete response
8.Adequate hematologic and organ function, defined by the following laboratory results, to be obtained within 7 days prior to registration and prior to first dose of study drug treatment:
•Absolute neutrophilic count > 1,0 x 109/L
•Platelet count = 75 x 109/L
•Hemoglobin = 8,5 g/dL
•Albumin = 2.5 g/dL
•Bilirubin = 1.5 x the upper limit of normal (ULN) or within 3 x ULN for patients with documented Gilbert syndrome
•AST, ALT, and AP = 3 x ULN
•Serum creatinine = 1.5 x ULN
9.Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use 2 effective forms of contraception during the course of this study. Females have to continue to always use 2 effective forms of contraception for at least 24 months after completion of study therapy, and males for at least 2 months after end of therapy. Breast feeding is likewise not allowed for at least 24 months after completion of study therapy.
•Females of childbearing potential are defined as sexually mature women without prior hysterectomy and who have had menses within the last 12 months.
•Females are considered NOT to be of childbearing potential if amenorrheic for >12 months and follicle-stimulating hormone (FSH) level = 40 IU/L.
•Females who are amenorrheic = 2 years, FSH requirement are waived.
•Effective forms of contraception includes surgical sterilization, a reliable barrier method with spermicidal, birth control pills, or contraceptive hormone implants
•Female patients of childbearing potential who desire to have children in the future should be informed about measures regarding conservation of fertility
10.Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential (including pre-menopausal women with tubal ligation).
11.Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and follow-up as defined by the treatment discontinuation schedule.
12.Agreement not to donate blood or blood products during the study and for at least 24 months after discontinuation of vismodegib. Because vismodegib has been detected in seminal fluid, in addition for men, agreement not donate sperm during the study or for at least 2 months after discontinuation of therapy.
13. Optional: Consent to undergo non-invasive imaging examinations by means of confocal laserscan-microscopy (CLSM) and/or optical coherence tomography (OCT), during and after end of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age ra
1.History of prior treatment with vismodegib or any other hedgehog pathway inhibitor.
2.Radiotherapy that involved the field of the target lesion(s) within 6 months prior to registration. Only one radiotherapy of the target lesion(s) performed > 6 months prior to registration is allowed. If a second radiotherapy in this field took place, patient will be excluded.
3.Any metastatic BCC
4.Metatypic BCC
5.Known or suspected Gorlin-Goltz syndrome
6.Uncontrolled medical illness, including advanced malignancies (no activities of the malignancies in the past 3 years), at the discretion of the Investigator
7.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
8.History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
9.Any medical or psychological illness or condition preventing adequate consent or ability to comply with the protocol
10.Inability or unwillingness to swallow capsules
11.Inability or unwillingness to comply with study and follow-up procedures
12.Current severe, uncontrolled systemic disease
13.History of malabsorption or other conditions that would interfere with the absorption of the orally applicated study drug
14.Pregnant, lactating, or breast feeding women
15.Patients with one of the following rare hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption
16.Participation in another clinical drug study within 28 days before registration
17.Known or suspected alcohol or drug abuse in the opinion of the investigator
18.Known hypersensitivity reaction to vismodegib or any of the other ingredients of this medicine
19.Treatment with St John’s wort (Hypericum perforatum)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method