NCT02691780WithdrawnNot Applicable
Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Samsung Medical Center
- Locations
- 1
- Primary Endpoint
- Progression Free survival
Study Overview
Brief Summary
This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation Refractory solid tumor and specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of fully informed consent prior to study specific procedures.
- •Patients must be >= 19 years of age
- •BRAF mutation, Refractory solid tumor and/or specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
- •ECOG Performance status0-2
- •Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
- •Adequate Organ Function Laboratory values
- •Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL, Platelets>=100x 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 subject with liver metastases) Creatinine<= 1.5 X UNL
- •Patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing
- •Adequate heart function
Exclusion Criteria
- •Patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for <= 5 years.
- •Has known active central nervous system(CNS) metastases
- •Has an active infection requiring systemic therapy
- •Pregnancy or breast feeding
- •Patients with cardiac problem
- •Any previous treatment with Sorafenib
Arms & Interventions
Sorafenib
Experimental
Sorafenib 200mg bid will be administered orally daily every 3weeks
Intervention: Sorafenib (Drug)
Outcomes
Primary Outcomes
Progression Free survival
Time Frame: 24 months
Secondary Outcomes
- Time to progression(24 months)
- Overall Response Rate(24 months)
- Overall survival(24 months)
- Number of subjects with Adverse Events as a measure of safety(24 months)
Investigators
Seung tae Kim
Principal Investigator
Samsung Medical Center
Study Sites (1)
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