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OpenTrials
Completed

NCT Number: NCT02450149

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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

Treatment and study plan

Sorafenib

Drug

Other names: Nexavar

Primary outcomes

  1. progression-free survival

    Time frame: expected average of 24 weeks

Secondary outcomes

  1. objective response rate

    Time frame: expected average of 24 weeks

  2. Time to progression

    Time frame: expected average of 24 weeks

  3. overall survival

    Time frame: expected average of 24 weeks

  4. Number of subjects with Adverse Events as a measure of toxicity profile

    Time frame: expected average of 24 weeks

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 21, 2015
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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