Clinical trial · Interventional
The Effects of Sorafenib on Molecular Barrett's Esophagus Cancer
A Pilot Study of the Effect of Sorafenib on Molecular Biomarkers in Barrett's Esophagus With High Grade Dysplasia
NCT00619242CI-TRIAL-00014007Barrett'sterminatedN/AResults postedClinicalTrials.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): Low accrual
Summary
Brief summary (as posted)
To determine whether sorafenib is able to change pre-cancerous cells in a way that we believe is important in the progression of cancer.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sorafenib
- description
- sorafenib 2 tablets by mouth
- interventionNames
- Drug: sorafenib
Primary outcomes (1)
- measure
- Ki-67
- timeFrame
- Two weeks
- description
- Biomarker. Change in Ki-67 staining between pre- and on-therapy biopsies in patients with Barrett's esophagus.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG performance status 0-2 * Life expectancy of greater than 12 months * No prior history of esophageal surgery or endoscopic treatment of dysplasia * No prior exposure to sorafenib * Patients may not be receiving any other investigational agents or any concomitant antineoplastic therapy, with the exception of androgen ablating agents (for patients with prior prostate cancer) * Age 18 years. * Patients must have adequate organ and marrow function as defined below: * hemoglobin: 8.5 g/dL * absolute neutrophil count: 1,500/L * platelets: 100,000/L (greater than 35,000/L without transfusion for less than 1 X the institutional upper limit of normal) * creatinine less than 1.5 X institutional upper limit of normal * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * A patient will be withdrawn from the study if any of the following events occur while on therapy: * Interruption of scheduled therapy for greater than 7 days * Intolerable adverse effects which are judged by the investigator to be either physically or psychologically detrimental to the patient * Patient decision to discontinue treatment * Pregnancy * Patient non-compliance with therapy administration * Grade 3 or 4 NCI-CTC toxicity attributable to sorafenib * Treatment with other chemotherapeutic or investigational anti-neoplastic drugs * Disease progression * HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
References
Publications (0)
Data not yet available
No reference posted for this study.