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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01033019




Registration number
NCT01033019
Ethics application status
Date submitted
15/12/2009
Date registered
16/12/2009
Date last updated
30/10/2015

Titles & IDs
Public title
To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)
Scientific title
Double-blind, Randomized, Vehicle-controlled Proof of Concept Study on the Efficacy, Safety, Local Tolerability, PK and Pharmacodynamics of Multiple Topical Administrations of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Secondary ID [1] 0 0
2009-013665-26
Secondary ID [2] 0 0
CLDE225B2204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sporadic Superficial and Nodular Skin Basal Cell Carcinomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LDE225 0.75%
Treatment: Drugs - Vehicle

Experimental: LDE225 0.75% - Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.

Placebo Comparator: Vehicle - Participants topically applied matching placebo cream twice daily for 6 weeks.


Treatment: Drugs: LDE225 0.75%
0.75% cream

Treatment: Drugs: Vehicle
matching placebo cream to 0.75% LDE225 cream

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Evaluation of sBCCs Tumors - 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).
Timepoint [1] 0 0
Day 43

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Benowa
Recruitment hospital [2] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
4217 - Benowa
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT01033019
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01033019