To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)

Phase 2

Terminated

• Conditions: Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
• Interventions: Drug: LDE225 0.75%; Drug: Vehicle

• Registration Number: NCT01033019
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week after final study drug administration (Day 50), a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2015-08-18
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-01
• Last Update Submitted: 2015-10-01
• Results First Posted: 2015-10-30
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Patients with one histologically confirmed superficial and nodular basal cell carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs)

Exclusion Criteria

• Previous treatment of the sBCC that are selected for treatment.
• Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.
• Dark-skinned persons whose skin color prevents readily assessment of skin reactions

Other protocol defined Incl./Excl. criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDE225 0.75%	LDE225 0.75%	Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
Vehicle	Vehicle	Participants topically applied matching placebo cream twice daily for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Clinical Evaluation of sBCCs Tumors	Day 43	The clinical response parameters were defined as (i) complete response (i.e., there is no longer any visible evidence of a lesion consistent with BCC at this site), (ii) partial response (i.e., although a BCC still remains at this site, it has demonstrated a visible decrease in size compared with baseline), and (iii) no response / worsening (i.e., the BCC has not demonstrated any visible decrease in size compared with baseline).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇹 Wien, Austria