locally advanced or metastatic basal cell carcinoma MedDRA version: 14.1 Level: LLT Classification code 10066495 Term: Basal cell carcinoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: LDE225
Pharmaceutical Form: Capsule
INN or Proposed INN: Erismodegib
CAS Number: 1218778-77-8
Current Sponsor code: LDE225
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to meet all of the following criteria: 1. Age 18 years or older 2. Patient with locally advanced BCC or metastatic BCC 3. WHO performance status = 2 4. Patients with adequate bone marrow, liver and renal function 5. Written informed consent obtained prior to any screening procedures Other protocol defined inclusion criteria may apply 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 105 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 105
Exclusion criteria
Exclusion criteria: Patients eligible for this study must not meet any of the following criteria: 1. Patients who have had major surgery within 4 weeks of initiation of study medication. 2. Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data. 3. Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes. 4. Patients who have previously been treated with systemic LDE225 or with other Hh pathway inhibitors. 5. a) Patients who have neuromuscular disorders or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis and that cannot be discontinued at least 2 weeks prior to starting LDE225 treatment. b) Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. NB: Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on LDE225 treatment. 6. Patients who have taken part in an experimental drug study within 4 weeks of initiating treatment with LDE225. 7. Patients who are receiving other anti-neoplastic therapy concurrently or within 4 weeks of starting treatment with LDE225. 8. Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225. 9. Pregnant or nursing (lactating) women 10. Women of child-bearing potential unless they are using two forms of highly effective contraception 11. Fertile males not willing to use condoms 12. Patients unwilling or unable to comply with the protocol. Other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of LDE225 as measured by Objective Response Rate (ORR) in patients with locally advanced or metastatic basal cell carcinoma.; Secondary Objective: - To asses the time to tumor response (TTR) - To assess duration of overall response (DoR). - To assess the effect of LDE225 therapy on progression-free survival (PFS). - To assess the effect of LDE225 therapy on overall survival (OS). - To characterize the safety of LDE225 therapy. - To further characterize the pharmacokinetics of LDE225 ;Primary end point(s): Objective response rate (ORR);Timepoint(s) of evaluation of this end point: Primary analysis will occur when all patients have been treated for 24 weeks or have discontinued | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to tumor response (TTR) Duration of overall response (DoR) Progression-free survival (PFS) Overall survival (OS) Frequency and severity of adverse events, new or worsened laboratory results and other safety data from other tests (e.g. electrocardiogram or vital signs) PK (Cmin, steady-state trough concentration) ;Timepoint(s) of evaluation of this end point: Primary analysis will occur when all patients have been treated for 24 weeks or have discontinued | — |
Countries
Australia, Belgium, Canada, Germany, Greece, Hungary, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactRoel Divendal
Novartis Pharma BV
Outcome results
None listed