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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2009

Last Updated Date

October 1, 2015

Start Date ^ICMJE

December 2009

Primary Completion Date

February 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Clinical evaluation of sBCCs tumors (complete response, partial response, no response / worsening) [ Time Frame: 12 weeks ]

Change History

Complete list of historical versions of study NCT01033019 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Serious adverse events, adverse events, local tolerability [ Time Frame: 13 weeks ]
Histological signs of tumor regression; apoptosis, tumor proliferation markers in sBCC [ Time Frame: 12 weeks ]
Specific biomarkers related to the Smo pathway (Gli1, Gli2, Ptch1 and Ptch2) in BCC tumor tissue and expression of Gli1 by immunohistochemistry [ Time Frame: 6 weeks ]
LDE225 pharmacokinetics in plasma and skin [ Time Frame: 13 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Sporadic Superficial and Nodular Skin Basal Cell Carcinomas

Intervention ^ICMJE

Drug: LDE225 0.75%
0.75% cream
Drug: Vehicle
matching placebo cream to 0.75% LDE225 cream

Study Arms

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

Intervention: Drug: LDE225 0.75%
Placebo Comparator: Vehicle
Participants topically applied matching placebo cream twice daily for 6 weeks.

Intervention: Drug: Vehicle

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

February 2011

Primary Completion Date

February 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Austria

Removed Location Countries

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01033019

Other Study ID Numbers ^ICMJE

CLDE225B2204
2009-013665-26
EudraCT 2009-013665-26

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

PRS Account

Novartis

Verification Date

October 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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