Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors

Not Applicable

Withdrawn

• Conditions: Refractory Solid Tumors
• Interventions: Drug: Sorafenib

• Registration Number: NCT02691780
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-22
• Study First Posted: 2016-02-25
• Study Start: 2016-12-23
• Primary Completion: 2018-12
• Study Completion: 2019-11-19
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib	Sorafenib	Sorafenib 200mg bid will be administered orally daily every 3weeks

Primary Outcome Measures

Name	Time	Method
Progression Free survival	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Seoul, Korea, Republic Of, Korea, Republic of