Clinical trial · Interventional
Sorafenib in Treating Patients With Advanced Malignant Solid Tumors
Single Agent Sorafenib in Advanced Solid Tumors: Phase II Evaluation of Dose Re-Escalation Following a Dose Reduction (IST000375)
NCT00810394CI-TRIAL-00031120completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to see how well it works in treating patients with advanced malignant solid tumors.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib
- description
- Dose Re-Escalation Following a Dose Reduction
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Percentage of Patients Tolerating Re-escalated Dose of Sorafenib for 28 Days Without Dose Interruption or De-escalation for Toxicity
- timeFrame
- At least 3 months
- description
- Overall percentage of patients tolerating a dose escalation to 600 mg twice daily for 28 days plus the percentage tolerating a re-escalation to 400 mg twice daily in Cycle 3.
Secondary outcomes (2)
- measure
- Overall Response Rate
- timeFrame
- At least 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective or solid tumor for which sorafenib is considered acceptable therapy * Age \> 18 years old * Performance Status 0 - 2 * Measurable or non-measurable disease. * Adequate bone marrow, liver and renal function * Any number of prior chemotherapy regimens are allowed. * Any prior chemotherapy, immunotherapy or targeted therapy must have been completed at least 2 weeks prior to start of this protocol and all side effects resolved to grade 1 or less. Any prior radiation must have been completed at least 2 weeks prior to start of therapy. * Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment * Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib. * Ability to understand and the willingness to sign a written informed consent. * International normalized ratio \< 1.5 or a Prothrombin Time/Partial thromboplastin time within normal limits. Exclusion Criteria * Prior therapy with sorafenib or sunitinib. * Cardiac disease: Congestive heart failure \> class II New York Heart Association. * Symptomatic or uncontrolled brain metastasis. * No component of squamous carcinoma can be present in any patient with non-small cell lung cancer * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. * Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management. * Known HIV infection or chronic Hepatitis B or C. * Active clinically serious infection \> CTCAE Grade 2. * Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months. * Pulmonary hemorrhage/bleeding event \> CTCAE Grade 2 within 4 weeks of first dose of study drug. * Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug. * Serious non-healing wound, ulcer, or bone fracture. * Evidence or history of bleeding diathesis or coagulopathy * Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug. * Use of St. John's Wort or rifampin * Known or suspected allergy to sorafenib or any agent given in the course of this trial. * Any condition that impairs patient's ability to swallow whole pills. * Any significant malabsorption problem. * Therapy with bevacizumab \< 3 months prior to first dose of study drug.
References
Publications (1)
- RESULTSemrad TJ, Eddings C, Pan CX, Lau DH, Gandara D, Beckett L, Lara PN Jr. Feasibility study of intra-patient sorafenib dose-escalation or re-escalation in patients with previously treated advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):2001-7. doi: 10.1007/s10637-011-9761-y. Epub 2011 Oct 21. PMID 22015991