EUCTR2012-004113-13-BEActive, not recruitingNot Applicable
A Phase II, Open-Label, Safety, Efficacy and Pharmacodynamic Study of oral sonidegib in patients with Basal Cell Carcinoma (BCC) and prior exposure to Hedgehog Pathway inhibitors - SALSA
GZA vzw, GZA Ziekenhuizen, Sint-Augustinus0 sitesStarted: October 4, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •?Understand and voluntarily sign an Institutional Review Board/Independent Ethics Committee-approved informed consent form prior to any study-specific evaluation
- •?Be 18 years of age at the time the informed consent form is signed
- •?Have an Eastern Cooperative Oncology Group performance status of 0 to 1
- •?Have life expectancy of at least 3 months
- •?Have adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of LDE
- •Bone marrow function
- •ANC > 1,5 x 109/L
- •Platelets > 100 x 109/L
- •Hemoglobin > 9 g/dL
- •Hepatic function
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN); if liver metastases then < 5 x ULN, Bilirubin < 1,5 x ULN
- •Renal function
- •Serum creatinine < 1,5 x ULN
- •?Have a normal clinical cardiac evaluation
- •?Have a histologically or cytologically proven BCC
- •?Have evidence of measurable disease as defined by RECIST Version 1.1 or have lesions that can be biopsied and can be photographically assessed
- •?Must have been pretreated with either vismodegib or sonidegib
- •?Must have progressed or became intolerant for further treatment with vismodegib or have progressed after having experienced clinical benefit of treatment with sonidegib
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
Exclusion Criteria
- •?History of prior malignancy except:
- •Curatively treated in-situ cervical cancer
- •Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •?Untreated or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks
- •?Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- •Unstable angina pectoris
- •Acute myocardial infarction
- •?Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C
- •?Treatment with chemotherapy, radiation, hormones (except corticosteroids and megestrol acetate), antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitor, or experimental drugs 14 days prior to first scheduled dose of sonidegib and/or ongoing adverse effects from such treatment > NCI CTCAE Grade 1
- •?Treament with HPI needs to be discontinued for at least 2 weeks
- •?Females who are pregnant or breastfeeding
- •?For fertile patients (male and female), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of sonidegib
- •?Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g. substance abuse, psychiatric disturbance, or uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism)
- •?Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.
Investigators
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