Sorafenib in Newly Diagnosed High Grade Glioma
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ClinicalTrials.gov Identifier: NCT00884416 |
Recruitment Status
:
Completed
First Posted
: April 20, 2009
Last Update Posted
: November 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Gliosarcoma Anaplastic Astrocytoma Anaplastic Oligoastrocytoma Anaplastic Oligodendroglioma | Drug: Sorafenib dose escalation | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2009 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Sorafenib dose titration |
Drug: Sorafenib dose escalation
Sorafenib dose escalation scheme: 3 first patients: 200 mg/d, if dose limiting toxicities (DLT) not reached: 3 patients at 200 mg BID, if no DLT reached: 3 patients at 400 mg bid
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- Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy [ Time Frame: 35 weeks ]Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy in patients with newly diagnosed high grade glioma
- Maximum Observed Plasma Concentration (Cmax) and Area under the curve (AUC) of sorafenib and temozolomide [ Time Frame: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose ]
- Response rate [ Time Frame: 35 weeks ]
- Time to treatment failure [ Time Frame: 20 months ]
- 6 month progression-free survival [ Time Frame: 6 months ]
- Event free survival [ Time Frame: 20 months ]
- Overall survival [ Time Frame: 20 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884416
Switzerland | |
Geneva University Hospital (Hopitaux Universitaires de Geneve), Department of Oncology | |
Geneva, GE, Switzerland, 1211 |
Principal Investigator: | Pierre-Yves Dietrich, MD | Department of oncology, Geneva University hospital |
Publications of Results:
Responsible Party: | Andreas F. Hottinger, Principal Investigator, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00884416 History of Changes |
Other Study ID Numbers: |
08-122 2009DR1029 13031 |
First Posted: | April 20, 2009 Key Record Dates |
Last Update Posted: | November 4, 2014 |
Last Verified: | October 2014 |
Keywords provided by Andreas F. Hottinger, University Hospital, Geneva:
anaplastic oligodendroglioma high grade glioma glioblastoma gliosarcoma anaplastic astrocytoma anaplastic oligoastrocytoma phase I |
first line treatment sorafenib temozolomide radiation therapy safety tolerability protein kinase inhibitors |
Additional relevant MeSH terms:
Glioblastoma Glioma Astrocytoma Gliosarcoma Oligodendroglioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Sorafenib |
Temozolomide Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents, Alkylating Alkylating Agents |