Nevoid Basal Cell Carcinoma Syndrome
Conditions
Brief summary
A discontinuation rate <54% due to AEs at 40 weeks from study entry in a NBCCS - population/sporadic BCC patients in EADO stage IIb treated for 16 weeks with daily sonidegib followed by a pulsed dosing for the subsequent 24 weeks.
Detailed description
The ORR according to RECIST criteria., The PFS at 40 weeks from study entry., The DOR of a pulsed sonidegib regimen., The rate of any grade drug related (DR) AEs and G3/4 DR AEs of a pulsed sonidegib regimen in a NBCCS - population / sporadic BCC patients in EADO stage IIb after 16 weeks with daily sonidegib., The EORTC QLQ C30 score at baseline, after 16 weeks of continuous daily sonidegib therapy, and after 24 weeks of pulsed sonidegib regimen.
Interventions
Sponsors
Gruppo Oncologico Del Nord Ovest
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A discontinuation rate <54% due to AEs at 40 weeks from study entry in a NBCCS - population/sporadic BCC patients in EADO stage IIb treated for 16 weeks with daily sonidegib followed by a pulsed dosing for the subsequent 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The ORR according to RECIST criteria., The PFS at 40 weeks from study entry., The DOR of a pulsed sonidegib regimen., The rate of any grade drug related (DR) AEs and G3/4 DR AEs of a pulsed sonidegib regimen in a NBCCS - population / sporadic BCC patients in EADO stage IIb after 16 weeks with daily sonidegib., The EORTC QLQ C30 score at baseline, after 16 weeks of continuous daily sonidegib therapy, and after 24 weeks of pulsed sonidegib regimen. | — |
Countries
Italy
Outcome results
None listed