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

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Samsung Medical Center

Status

Withdrawn

Conditions

Refractory Solid Tumors

Treatments

Drug: Sorafenib

Study type

Interventional

Funder types

Other

Identifiers

NCT02691780
2016-02-097

Details and patient eligibility

About

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.

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Sorafenib
Experimental group
Description:
Sorafenib 200mg bid will be administered orally daily every 3weeks
Treatment:
Drug: Sorafenib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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