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

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ClinicalTrials.gov Identifier: NCT01033019
Recruitment Status : Terminated (The data from participants with sBCCs showed insufficient efficacy with current formulation and treatment conditions.)
First Posted : December 16, 2009
Results First Posted : October 30, 2015
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sporadic Superficial and Nodular Skin Basal Cell Carcinomas Drug: LDE225 0.75% Drug: Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Sonidegib

Arms and Interventions
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Arm Intervention/treatment
Experimental: LDE225 0.75%
Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
 Drug: LDE225 0.75%
0.75% cream
Placebo Comparator: Vehicle
Participants topically applied matching placebo cream twice daily for 6 weeks.
 Drug: Vehicle
matching placebo cream to 0.75% LDE225 cream


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Evaluation of sBCCs Tumors [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033019


Locations
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Australia, Queensland
Novartis Investigative Site
Benowa, Queensland, Australia, 4217
Novartis Investigative Site
Woolloongabba, Queensland, Australia, 4102
Austria
Novartis Investigative Site
Graz, Austria, A-8036
Novartis Investigative Site
Wien, Austria, 1090
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01033019    
Other Study ID Numbers: CLDE225B2204
2009-013665-26
EudraCT 2009-013665-26
First Posted: December 16, 2009    Key Record Dates
Results First Posted: October 30, 2015
Last Update Posted: October 30, 2015
Last Verified: October 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Basal cell carcinomas,
sporadic,
superficial and nodular,
skin
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell