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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013665-26 | |||
| EudraCT 2009-013665-26 |
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The data from participants with sBCCs showed insufficient efficacy with current formulation and treatment conditions.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDE225 0.75% | Experimental | Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. |
|
| Vehicle | Placebo Comparator | Participants topically applied matching placebo cream twice daily for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDE225 0.75% | Drug | 0.75% cream |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Evaluation of sBCCs Tumors | 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). | Day 43 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined Incl./Excl. criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Benowa | Queensland | 4217 | Australia | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Twenty-five participants were enrolled into the trial. However, one participant was excluded from the efficacy analysis. Therefore, the enrollment number differs from the number started below.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDE225 0.75% | Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. |
| FG001 | Vehicle | Participants topically applied matching placebo cream twice daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
matching placebo cream to 0.75% LDE225 cream |
|
| Woolloongabba |
| Queensland |
| 4102 |
| Australia |
| Novartis Investigative Site | Graz | A-8036 | Austria |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LDE225 0.75% | Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. |
| BG001 | Vehicle | Participants topically applied matching placebo cream twice daily for 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Evaluation of sBCCs Tumors | 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). | Efficacy analysis set: the efficacy analysis set included all randomized participants with evaluable data. | Posted | Number | Participants | Day 43 |
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The nBCC participant from the LDE225 75% group was analyzed for safety as a separate arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDE225 0.75% - sBCC | Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks. | 0 | 16 | 8 | 16 | ||
| EG001 | Vehicle - sBCC | Participants topically applied matching placebo cream twice daily for 6 weeks. | 0 | 8 | 5 | 8 | ||
| EG002 | LDE225 0.75% - nBCC | 0 | 1 | 1 | 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival cyst | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Application site dermatitis | General disorders | MedDRA | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA | Systematic Assessment |
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| Local swelling | General disorders | MedDRA | Systematic Assessment |
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| Acute tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Application site folliculitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA | Systematic Assessment |
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| Glomerular filtration rate increased | Investigations | MedDRA | Systematic Assessment |
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| Glucose urine present | Investigations | MedDRA | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
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| Male |
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| No response |
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