Clinical trial · Interventional
Activity of Sorafenib in Salivary Gland Cancer
Sorafenib in Recurrent and/or Metastatic Salivary Gland Carcinomas: Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary objectives.
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 |
|---|---|---|---|
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib 400 mg twice daily
- description
- Sorafenib 400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Objective response
- timeFrame
- 8 weeks
- description
- Response Rate according to RECIST criteria. Response will be evaluated every 2 months.
Secondary outcomes (2)
- measure
- response rate according to CHOI criteria
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven relapsed and/or metastatic salivary gland cancer for which potentially curative options such as surgery or radiotherapy are not indicated * One target lesion measurable by CT-scan or MRI according to RECIST criteria * Age + 18 years * ECOG 0 or 1 * Adequate bone marrow, liver and renal function * Signed written informed consent Exclusion Criteria: * Symptomatic metastatic brain or meningeal tumors * History of cardiac disease such as congestive heart failure\>NYHA class 2 * Active CAD * Cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension * Pregnant or breast-feeding patient * Patients with evidence or history of bleeding diathesis * Patients undergoing renal dialysis * Patients unable to swallow oral medication
References
Publications (0)
Data not yet available