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

NCT02450149 | Completed

• 1 other identifier: 2015-02-002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  expected average of 24 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

Sorafenib

EXPERIMENTAL

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

Drug: sorafenib

Interventions

sorafenib DRUG

Also known as: Nexavar

Sorafenib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of fully informed consent prior to any study specific procedures.
• Patients must be ≥20 years of age.
• 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.
• ECOG performance status 0-2.
• Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
• 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
• 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.
• Adequate heart function.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, 135-710, South Korea

Location

MeSH Terms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 21, 2015
• Study Start: May 30, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 9, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

KR (1)