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| Name | Class |
|---|---|
| Sun Pharmaceutical Industries Limited | INDUSTRY |
| Zhejiang Hangyu Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a Phase IV, single arm, multicenter study designed to evaluate the efficacy and safety profile of Sonidegib in chinese participants with locally advanced basal cell carcinoma (laBCC) who are not amenable to radiation therapy, curative surgery or other local therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sonidegib Phosphate Capsules | Experimental | Participants will receive continuous treatment with oral administration once a day until conditions for treatment termination are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonidegib Phosphate Capsules | Drug | Sonidegib should be taken 1 hour before or 2 hours after a breakfast |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate (ORR) is defined as the percentage of participants with a confirmed complete or partial response (CR or PR) , per modified Response Evaluation Criteria in Solid Tumors (mRECIST) as assessed by central review. | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DoR) | The DOR for a responder is defined as the time from the participant's initial CR or PR to the first date of either disease progression or death, whichever occurs first. CR, PR and PD will be determined per mRECIST by investigator and central review, respectively | up to 1 year |
| Complete response rate (CRR) per central and investigator review |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hang Li | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China | 100034 | China |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018295 | Neoplasms, Basal Cell |
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CRR is defined as the percentage of participants who achieved a complete response per mRECIST |
| up to 1 year |
| Progression-free Survival (PFS) | PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first. Disease progression will be determined per mRECIST by investigator and central review, respectively | up to 1 year |
| Time to tumor response (TTR) | TTR is defined as the time from the participant's first dose of study treatment to the date of initial CR or PR. CR and PR will be determined per mRECIST by investigator and central review, respectively. | up to 1 year |
| Adverse event (AE)/Serious adverse event (SAE)/Treatment emergent adverse event (TEAE) | Adverse events, and changes from baseline in vital signs,etc | up to 1 year |