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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:
Novartis Pharmaceuticals
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
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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 (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 |
Resource links provided by NLM:
Further study details as provided by Novartis ( Novartis Pharmaceuticals ):
Primary Outcome Measures:
- 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).
| 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) |
| 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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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
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 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
|
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 July 17, 2017