Clinical trial · Interventional
Study to Evaluate the Safety and Efficacy of Sorafenib, in Subject With Refractory Solid Tumors
NCT02691780CI-TRIAL-00042516withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): not enrolled
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- Sorafenib 200mg bid will be administered orally daily every 3weeks
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Progression Free survival
- timeFrame
- 24 months
Secondary outcomes (4)
- measure
- Overall Response Rate
- timeFrame
- 24 months
- measure
- Time to progression
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.