- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02450149
Single-arm Study to Evaluate the Safety and Efficacy of Sorafenib, in Subjects With BRAF Mutation Refractory Solid Tumors
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.
Study Overview
Study Type
Enrollment (Actual)
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 any study specific procedures.
- Patients must be ≥20 years of age.
- 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.
- ECOG performance status 0-2.
- Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
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
- 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.
- 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 tumours curatively treated with no evidence of disease for ≤3 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 400 mg will be administered orally twice a day for 28 days.
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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: expected average of 24 weeks
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expected average of 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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objective response rate
Time Frame: expected average of 24 weeks
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expected average of 24 weeks
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Time to progression
Time Frame: expected average of 24 weeks
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expected average of 24 weeks
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overall survival
Time Frame: expected average of 24 weeks
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expected average of 24 weeks
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Number of subjects with Adverse Events as a measure of toxicity profile
Time Frame: expected average of 24 weeks
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expected average of 24 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
- 2015-02-002
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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