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

NCT ID: NCT02450149

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2016-08-09

Brief Summary

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.

Conditions

Refractory Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sorafenib

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

Group Type: EXPERIMENTAL

sorafenib

Intervention Type: DRUG

Interventions

sorafenib

Intervention Type: DRUG

Other Intervention Names

Nexavar

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seung tae Kim

MD,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, South Korea

Countries

South Korea

Other Identifiers

2015-02-002

Identifier Type: -

Identifier Source: org_study_id