melanoma
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : Dabrafenib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materi
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Completely resected histologically confirmed high-risk [Stage IIIa (LN metastasis >1 mm), IIIb or IIIc; refer to Appendix 1 for Staging Guidelines] cutaneous melanoma determined to be V600E/K mutation positive using the bioMerieux (bMX) THxID BRAF Assay. The testing will be conducted by a central reference laboratory. Patients presenting with initial resectable lymph node recurrence after a diagnosis of Stage I or II melanoma are eligible. Patients with an unknown primary melanoma are not eligible. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before randomization.
Exclusion criteria
Exclusion criteria: Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases. Evidence of distant metastatic disease on screening evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint of this study is relapse free survival (RFS) which is defined as the time from randomization to disease recurrence or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public ContactKyosuke Yamauchi
Novartis Pharma. K.K.
Outcome results
None listed