RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
Public ClinicalTrials.gov record NCT01119599. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1 Trial of RO4929097 in Combination With Standard Radiotherapy and Temozolomide for Newly Diagnosed Malignant Glioma: A Pharmacokinetic and Pharmacodynamic Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I trial studies the side effects and best dose of gamma-secretase/Notch signalling pathway inhibitor RO4929097 (RO4929097) when given together with temozolomide and radiation therapy in treating patients with newly diagnosed malignant glioma. Enzyme inhibitors, such as gamma-secretase/Notch signalling pathway inhibitor RO4929097, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gamma-secretase/Notch signalling pathway inhibitor RO4929097 together with temozolomide and radiation therapy may kill more tumor cells.
Study identification
- NCT ID
- NCT01119599
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 22 participants
Conditions and interventions
Conditions
- Acoustic Schwannoma
- Adult Anaplastic (Malignant) Meningioma
- Adult Anaplastic Astrocytoma
- Adult Anaplastic Ependymoma
- Adult Brain Stem Glioma
- Adult Choroid Plexus Neoplasm
- Adult Craniopharyngioma
- Adult Diffuse Astrocytoma
- Adult Ependymoblastoma
- Adult Ependymoma
- Adult Giant Cell Glioblastoma
- Adult Glioblastoma
- Adult Gliosarcoma
- Adult Grade I Meningioma
- Adult Grade II Meningioma
- Adult Medulloblastoma
- Adult Mixed Glioma
- Adult Myxopapillary Ependymoma
- Adult Oligodendroglioma
- Adult Papillary Meningioma
- Adult Pilocytic Astrocytoma
- Adult Pineal Gland Astrocytoma
- Adult Pineoblastoma
- Adult Pineocytoma
- Adult Primary Melanocytic Lesion of Meninges
- Adult Subependymal Giant Cell Astrocytoma
- Adult Subependymoma
- Adult Supratentorial Primitive Neuroectodermal Tumor
- Malignant Adult Intracranial Hemangiopericytoma
Interventions
- 3-Dimensional Conformal Radiation Therapy Radiation
- Gamma-Secretase Inhibitor RO4929097 Drug
- Intensity-Modulated Radiation Therapy Radiation
- Laboratory Biomarker Analysis Other
- Pharmacological Study Other
- Temozolomide Drug
- Therapeutic Conventional Surgery Procedure
Radiation · Drug · Other + 1 more
Eligibility (public fields only)
- Age range
- 19 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2010
- Primary completion
- May 31, 2013
- Completion
- Not listed
- Last update posted
- Sep 28, 2015
Started 2010
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01119599, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 28, 2015 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01119599 live on ClinicalTrials.gov.