---
title: Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors
nct_id: NCT02691780
overall_status: WITHDRAWN
phase: NA
sponsor: Samsung Medical Center
study_type: INTERVENTIONAL
primary_condition: Refractory Solid Tumors
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02691780.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02691780"
ct_last_update_post_date: 2019-12-30
last_seen_at: "2026-05-12T06:12:58.415Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors

**NCT ID:** [NCT02691780](https://clinicaltrials.gov/study/NCT02691780)

## Key Facts

- **Status:** WITHDRAWN
- **Why Stopped:** not enrolled
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Samsung Medical Center
- **Conditions:** Refractory Solid Tumors
- **Start Date:** 2016-12-23
- **Completion Date:** 2019-11-19
- **CT.gov Last Update:** 2019-12-30

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Sorafenib** (EXPERIMENTAL) — Sorafenib 200mg bid will be administered orally daily every 3weeks

## Interventions

- **Sorafenib** (DRUG)

## Primary Outcomes

- **Progression Free survival** _(time frame: 24 months)_

## Secondary Outcomes

- **Overall Response Rate** _(time frame: 24 months)_
- **Time to progression** _(time frame: 24 months)_
- **Overall survival** _(time frame: 24 months)_
- **Number of subjects with Adverse Events as a measure of safety** _(time frame: 24 months)_

## Locations (1)

- Samsung Medical Center, Seoul, Seoul, Korea, Republic of, South Korea

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.samsung medical center|seoul|seoul, korea, republic of|south korea` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02691780.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02691780*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*