Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 32 for:    "Nevoid basal cell carcinoma syndrome"

Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070691
Recruitment Status : Withdrawn
First Posted : March 3, 2017
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Drug: LDE225B Drug: Vehicle Phase 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Vehicle-controlled, Multicenter Trial of Topically Administered LDE225 Cream (0.75% Bid) to Evaluate Clearance of Basal Cell Carcinoma in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome


Arm Intervention/treatment
Active Comparator: LDE225 0.75% cream Drug: LDE225B
Cream, 2x daily

Placebo Comparator: Vehicle Drug: Vehicle
cream, 2x daily




Primary Outcome Measures :
  1. To demonstrate superiority of topical LDE225 versus vehicle in terms of treatment success in patients with NBCCs. Measure: Complete clinical clearance and complete histological clearance of BCCs [ Time Frame: 4 weeks after LDE225 treatment ]

Secondary Outcome Measures :
  1. To assess the safety of topical treatment with LDE225, compared to vehicle. Measure: Reported systemic adverse events in patients with NBCCS [ Time Frame: Treatment phase and up to 4 weeks after LDE225 treatment ]
  2. To evaluate the local tolerability of topical treatment with LDE225, compared to vehicle. Measure:Reported local adverse events in patients with NBCCS [ Time Frame: Treatment phase and up to 4 weeks after LDE225 treatment ]
  3. To assess the rate of complete clinical clearance of BCCs in patients with NBCCS. Measure: No clinical residual signs of carcinoma [ Time Frame: 4 weeks after LDE225 treatment ]
  4. To assess the rate of complete histological clearance of BCCs in patients with NBCCS. Measure: No residual tumor tissue [ Time Frame: 4 weeks after LDE225 treatment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult greater than 18 years old, male or female.
  2. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
  3. Typical presentation of NBCCS in the opinion of the investigator
  4. At least one of the major clinical criteria of NBCCS.
  5. Multiple BCCs during the screening period

Exclusion Criteria:

  1. Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator.
  2. Prior exposure to LDE225.
  3. Use of systemic treatment for BCC in the 4 weeks prior to Baseline.
  4. Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline.
  5. Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer.
  6. Clinically significant medical condition, as per judgment of the investigator.
  7. History of hypersensitivity to any of the ingredient of the study drug.
  8. Pregnant or nursing (lactating) women
  9. Women of child-bearing potential and fertile males, UNLESS they are using two birth control methods

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT03070691


  Show 35 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03070691     History of Changes
Other Study ID Numbers: CLDE225B2307
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: February 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Basal cell carcinoma
Nevoid Basal Cell Carcinoma Syndrome
NBCCS, Gorlin syndrome
Gorlin-Goltz Syndrome
Basal Cell Nevus Syndrome
BCNS, Hedgehog pathway inhibitor
topical
Smoothened
Additional relevant MeSH terms:
Layout table for MeSH terms
Basal Cell Nevus Syndrome
Carcinoma
Carcinoma, Basal Cell
Syndrome
Disease
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Cysts
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn