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

Not Applicable

Completed

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

• Registration Number: NCT02450149
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Study Start: 2016-05-30
• Primary Completion: 2016-08
• Study Completion: 2016-08-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib	sorafenib	Sorafenib 400 mg will be administered orally twice a day for 28 days.

Primary Outcome Measures

Name	Time	Method
progression-free survival	expected average of 24 weeks

Secondary Outcome Measures

Name	Time	Method
objective response rate	expected average of 24 weeks
Time to progression	expected average of 24 weeks
overall survival	expected average of 24 weeks
Number of subjects with Adverse Events as a measure of toxicity profile	expected average of 24 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, seoul, korea, Republic of, Korea, Republic of