Overview

This trial is active, not recruiting.

Condition basal cell carcinoma
Treatment lde225
Phase phase 2
Target SMO
Sponsor Novartis Pharmaceuticals
Start date June 2011
End date July 2016
Trial size 227 participants
Trial identifier NCT01327053, 2010-022629-14, CLDE225A2201

Summary

This study will assess the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
The study is double blinded and will enroll at least 100 and 50 evaluable patients on 800 mg and 200 mg LDE225 arms respectively. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
lde225
LDE225 will be prescribed by the investigator. LDE225 will be administered orally, on a continuous once daily dosing schedule. LDE225 will be supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day if study visit, patients will receive a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients will receive 4 capsules of LDE225 and 200 mg dose arm will receive 1 LDE225 capsule + 3 placebo capsules. The investigator must emphasize compliance and will instruct the patient to take LDE225 exactly as prescribed.
(Experimental)
The study is double blinded and will enroll at least 100 and 50 evaluable patients on 800 mg and 200 mg LDE225 arms respectively. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
lde225
LDE225 will be prescribed by the investigator. LDE225 will be administered orally, on a continuous once daily dosing schedule. LDE225 will be supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day if study visit, patients will receive a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients will receive 4 capsules of LDE225 and 200 mg dose arm will receive 1 LDE225 capsule + 3 placebo capsules. The investigator must emphasize compliance and will instruct the patient to take LDE225 exactly as prescribed.

Primary Outcomes

Measure
rate of objective response after 6 months of treatment
time frame: 6 months

Secondary Outcomes

Measure
Duration of response (DoR) as the time from the first observed confirmed response (CR or PR) to disease progression or death due to any reason.
time frame: Baseline, every 4 weeks up to week 17, every 8 weeks during the first year and every 12 weeks thereafter
Rate of complete response in patients treated with LDE225 as determined by central review and site investigator
time frame: Baseline, every 4 weeks up to week 17, every 8 weeks during the first year and every 12 weeks thereafter
Progression free survival in patients treated with LDE225 as determined by central review and site investigator
time frame: Baseline, every 4 weeks up to week 17, every 8 weeks during the first year and every 12 weeks thereafter
Time to tumor response in patients treated with LDE225 as determined by central review and site investigator
time frame: Baseline, every 4 weeks up to week 17, every 8 weeks during the first year and every 12 weeks thereafter
Rate of objective response rate in patients treated with LDE225 as determined by central review and site investigator
time frame: Baseline, every 4 weeks up to week 17, every 8 weeks during the first year and every 12 weeks thereafter
Changes in QT/QTc intervals and systemic drug exposure in patients treated with LDE225
time frame: Baseline, every 4 weeks
LDE225 systemic concentrations in patients treated with LDE225
time frame: Week 1, week 3, week 5, week 9, week 13 and every 12 weeks thereafter. Additional samples collected on week 17

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with locally advanced BCC and metastatic BCC - Patients with adequate bone marrow, liver, and renal function Exclusion Criteria: - Patients who have had major surgery within 4 weeks of initiation of study medication - Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes. - Patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study. - Patients with neuromuscular disorders or are on concurrent treatment with drugs that may cause muscle damage. - Patients who are on concurrent therapy with other anti-neoplastic agents. - Patients who have taken part in an experimental drug within 4 weeks of initiation of study medication. - Pregnant or nursing (lactating) women - Women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment - Fertile males not willing to use condoms throughout the study and for 3 months after the last treatment. - Patients who are unwilling or unable to comply with the protocol. Other protocol-defined inclusion/exclusion criteria may apply

Additional Information

Official title Phase II, Randomized Double-blind Study of Efficacy and Safety of Two Dose Levels of LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Novartis.