Refractory Solid Tumors
Conditions
Brief summary
This is a pilot study of sorafenib in patients with BRAF Mutation Refractory Solid Tumors. This study is a single-arm, pilot study of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation Sorafenib 400 mg will be administered orally twice a day for 28 days. To investigate the efficacy of sorafenib in patients with Refractory Solid Tumors harboring BRAF Mutation.
Interventions
DRUGsorafenib
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provision of fully informed consent prior to any study specific procedures. 2. Patients must be ≥20 years of age. 3. BRAF mutation Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy. 4. ECOG performance status 0-2. 5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator. 6. Adequate Organ Function Laboratory Values * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases) * creatinine ≤1.5 x UNL 7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing. 8. Adequate heart function.
Exclusion criteria
1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤3 years. 2. Has known active central nervous system (CNS) metastases. 3. Has an active infection requiring systemic therapy. 4. Pregnancy or breast feeding 5. Patients with cardiac problem. 6. Any previous treatment with sorafenib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | expected average of 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate | expected average of 24 weeks |
| Time to progression | expected average of 24 weeks |
| overall survival | expected average of 24 weeks |
| Number of subjects with Adverse Events as a measure of toxicity profile | expected average of 24 weeks |
Countries
South Korea
Outcome results
None listed