Single-arm Study to Evaluate the Safety and Efficacy of Sorafenib, in Subjects With BRAF Mutation Refractory Solid Tumors

Samsung Medical Center

Status: Completed

Conditions: Refractory Solid Tumors

Treatments: Drug: sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT02450149

2015-02-002

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of fully informed consent prior to any study specific procedures.

2. Patients must be ≥20 years of age.

3. 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.

4. ECOG performance status 0-2.

5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.

6. 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

7. 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.

8. Adequate heart function.

Exclusion criteria

1. 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.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. 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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1 participants in 1 patient group

Sorafenib

Experimental group

Description:

Sorafenib 400 mg will be administered orally twice a day for 28 days.

Treatment:

Drug: sorafenib