Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors

NCT02691780 | Withdrawn

• 1 other identifier: 2016-02-097
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single arm, pilot study of Sorafenib in patient with BRAF mutation Refractory solid tumor and specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. To investigate the efficacy and safety of Sorafenib in patient with Refractory solid tumor.

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Progression Free survival

  24 months

Secondary Outcomes (4)

• Overall Response Rate

  24 months

• Time to progression

  24 months

• Overall survival

  24 months

• Number of subjects with Adverse Events as a measure of safety

  24 months

Study Arms (1)

Sorafenib

EXPERIMENTAL

Sorafenib 200mg bid will be administered orally daily every 3weeks

Drug: Sorafenib

Interventions

Sorafenib DRUG

Also known as: Nexavar

Sorafenib

Eligibility Criteria

• Age: 19 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 study specific procedures.
• Patients must be \>= 19 years of age
• BRAF mutation, Refractory solid tumor and/or specific sensitivity to Sorafenib by Avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy.
• ECOG Performance status0-2
• Have measurable or evaluated disease based on RECIST 1.1 as determined by investigator.
• Adequate Organ Function Laboratory values
• Absolute neutrophil count \>= 1.5 x 109/L, Hemoglobin \>= 9g/dL, Platelets\>=100x 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 subject with liver metastases) Creatinine\<= 1.5 X UNL
• Patients of child-bearing potential should be using adequate contraceptive measures 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 tumor curatively treated with no evidence of disease for \<= 5 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: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: December 23, 2016
• Primary Completion: December 1, 2018
• Study Completion: November 19, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Locations

KR (1)