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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)

This study has been terminated.
(The data from participants with sBCCs showed insufficient efficacy with current formulation and treatment conditions.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01033019
First received: December 15, 2009
Last updated: October 1, 2015
Last verified: October 2015
  Purpose
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 Intervention Phase
Sporadic Superficial and Nodular Skin Basal Cell Carcinomas
Drug: LDE225 0.75%
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Clinical Evaluation of sBCCs Tumors [ Time Frame: Day 43 ] [ Designated as safety issue: No ]
    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).


Enrollment: 25
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033019

Locations
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01033019     History of Changes
Other Study ID Numbers: CLDE225B2204  2009-013665-26  EudraCT 2009-013665-26 
Study First Received: December 15, 2009
Results First Received: August 18, 2015
Last Updated: October 1, 2015
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Basal cell carcinomas,
sporadic,
superficial and nodular,
skin

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on December 05, 2016