Efficacy and safety of LDE225 in patients with locally advanced or metastatic basal cell carcinoma
- Conditions
- locally advanced or metastatic basal cell carcinomaMedDRA version: 19.0Level: LLTClassification code 10066495Term: Basal cell carcinoma recurrentSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022629-14-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
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
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
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 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)<br>- To assess duration of overall response (DoR).<br>- To assess the effect of LDE225 therapy on progression-free survival<br>(PFS).<br>- To assess the effect of LDE225 therapy on overall survival (OS).<br>- To characterize the safety of LDE225 therapy.<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): Time to tumor response (TTR)<br>Duration of overall response (DoR)<br>Progression-free survival (PFS)<br>Overall survival (OS)<br>Frequency and severity of adverse events, new or worsened laboratory results and other safety data from other tests (e.g. electrocardiogram or vital signs)<br>PK (Cmin, steady-state trough concentration)<br>;Timepoint(s) of evaluation of this end point: Primary analysis will occur when all patients have been treated for 24 weeks or have discontinued