Clinical trial · Interventional
Sorafenib in Newly Diagnosed High Grade Glioma
Phase I Dose Finding Study of Sorafenib in Combination With Radiation Therapy and Temozolomide as a First Line Treatment of Patients With High Grade Glioma
NCT00884416CI-TRIAL-00015980completedPhase 1ClinicalTrials.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)
This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination with Temodar and radiation therapy in patients with newly diagnosed high grade glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes it an interesting drug to investigate in the treatment of patients with high grade glioma as this agent has anti-angiogenic activity and inhibits other pathways such as Ras, Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which are potential targets against gliomas.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligoastrocytoma | Anaplastic Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligodendroglioma | Anaplastic Oligodendroglioma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib dose escalation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sorafenib dose titration
- interventionNames
- Drug: Sorafenib dose escalation
Primary outcomes (1)
- measure
- Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy
- timeFrame
- 35 weeks
- description
- Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy in patients with newly diagnosed high grade glioma
Secondary outcomes (6)
- measure
- Maximum Observed Plasma Concentration (Cmax) and Area under the curve (AUC) of sorafenib and temozolomide
- timeFrame
- 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological documentation of newly diagnosed malignant glioma * ECOG performance status of 0 or 1 * Age ≥18 * Life expectancy of at least 12 weeks * Hemoglobin ≥ 9.0 g/dl * Granulocyte count ≥1.5 X 10\^9/L * Platelet count ≥100 X 10\^9/L * SGOT ≤ 2.5X upper limit of normal (ULN) * SGPT ≤ 2.5X upper limit of normal (ULN) * Alkaline phosphatase ≤4x ULN * Serum creatinine ≤1.5X ULN * Bilirubin ≤1.5X ULN * Spontaneous PT-INR/PTT \< 1.5x upper limit of normal (patients on therapeutic anticoagulation will be allowed to participate. * Patients must be on a stable or decreasing dose of corticosteroids for at least 2 weeks * Patient for whom a first line treatment with temozolomide and radiotherapy is adequate * Prophylactic anti-emetic, pentamidine inhalation / co-trimoxazole and anticonvulsants are allowed * All patients must sign written informed consent. Exclusion Criteria: * Prior treatment for high grade glioma * Previous exposure to Ras pathway inhibitors * Other concurrent active malignancy (with the exception of cervical carcinoma in situ or non melanoma carcinoma of the skin, superficial bladder tumor \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry). * Serious medical or psychiatric illness that would, in the opinion of the investigator, interfere with the prescribed treatment, including but not limited to: Congestive heart failure \> NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrythmic therapy or uncontrolled hypertension within the last 12 months * Any condition limiting the patient's judgment capacity * History of HIV infection, chronic hepatitis C or B as well as clinically active infections (\> grade 2 NCI-CTC version 3.0) * History of organ allograft * Renal dialysis * Evidence or history of bleeding diathesis * Major surgery within 4 weeks of start of study treatment, except for neurosurgical resection * Autologous bone marrow transplant or stem cell rescue within 4 months of study * Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results. * Medical condition that prevents the patient from swallowing pills * Use of biologic response modifiers, such as G-CSF within 3 week of study entry. * Pregnant or breast-feeding women. * Refusal to use effective contraception. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for at least 3 months after administration of study medication. * Known or suspected allergy to the investigational agent or any agent given in association with this trial.
References
Publications (1)
- RESULTHottinger AF, Ben Aissa A, Espeli V, Squiban D, Dunkel N, Vargas MI, Hundsberger T, Mach N, Schaller K, Weber DC, Bodmer A, Dietrich PY. Phase I study of sorafenib combined with radiation therapy and temozolomide as first-line treatment of high-grade glioma. Br J Cancer. 2014 May 27;110(11):2655-61. doi: 10.1038/bjc.2014.209. Epub 2014 May 1. PMID 24786603