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

Samsung Medical Center

Status: Withdrawn

Conditions: Refractory Solid Tumors

Treatments: Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT02691780

2016-02-097

Details and patient eligibility

About

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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Sorafenib

Experimental group

Description:

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

Treatment:

Drug: Sorafenib