Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment
Conditions
Brief summary
Anti-tumor activity of vemurafenib in each cohort, as the primary objective of the trial, will be carried out by the determination of the confirmed objective response/remission rate (complete or partial response/remission) according to RECIST criteria v1.1 for solid tumors (appendix 8), IMWG Response Criteria for myeloma (appendix 9), and IWCLL for CLL
Detailed description
Disease control rate, Response duration, Progression-free survival, Overall Survival, Safety (CTCAE v4.0), Correlative research endpoints.
Interventions
Sponsors
Unicancer, Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-tumor activity of vemurafenib in each cohort, as the primary objective of the trial, will be carried out by the determination of the confirmed objective response/remission rate (complete or partial response/remission) according to RECIST criteria v1.1 for solid tumors (appendix 8), IMWG Response Criteria for myeloma (appendix 9), and IWCLL for CLL | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, Response duration, Progression-free survival, Overall Survival, Safety (CTCAE v4.0), Correlative research endpoints. | — |
Countries
France
Outcome results
None listed