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

Refractory Solid Tumors Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450149
• Other study ID #: 2015-02-002
• Status: Completed
• Phase: N/A
• First received: May 18, 2015
• Last updated: March 10, 2017
• Start date: May 30, 2016
• Est. completion date: August 9, 2016

Study information

• Verified date: March 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 9, 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractory Solid Tumors

Intervention

Drug:
• sorafenib

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	seoul, korea, Republic of

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		expected average of 24 weeks
Secondary	objective response rate		expected average of 24 weeks
Secondary	Time to progression		expected average of 24 weeks
Secondary	overall survival		expected average of 24 weeks
Secondary	Number of subjects with Adverse Events as a measure of toxicity profile		expected average of 24 weeks