- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02691780
Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors
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 Overview
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic Of
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Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sorafenib
Sorafenib 200mg bid will be administered orally daily every 3weeks
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free survival
Time Frame: 24 months
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24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Response Rate
Time Frame: 24 months
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24 months
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Overall survival
Time Frame: 24 months
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24 months
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Time to progression
Time Frame: 24 months
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24 months
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Number of subjects with Adverse Events as a measure of safety
Time Frame: 24 months
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24 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-02-097
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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