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NCT01119599 · ClinicalTrials.gov registry record · Phase 1
RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma
A Phase 1 study of Adult Anaplastic Astrocytoma and Adult Diffuse Astrocytoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT01119599: Completed Phase 1 study of Adult Anaplastic Astrocytoma and Adult Diffuse Astrocytoma, sponsored by National Cancer Institute (NCI).
NCT01119599 is a Phase 1 study of Adult Anaplastic Astrocytoma and Adult Diffuse Astrocytoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 22 participants, below the 49-participant average among 7 other Adult Anaplastic Astrocytoma trials with a reported enrollment target (55% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01119599, a Phase 1 study of Adult Anaplastic Astrocytoma and Adult Diffuse Astrocytoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
The percentage of patients who experience toxicity at each dose level will be calculated, with a 95% confidence interval.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION 3-Dimensional Conformal Radiation Therapy
- OTHER Pharmacological Study
- DRUG Gamma-Secretase Inhibitor RO4929097
Study Locations (2)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-05 |
| Phase | Phase 1 |
What the finished NCT01119599 record still lists
NCT01119599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 49-participant average among 7 other Adult Anaplastic Astrocytoma trials with a reported enrollment target (55% lower).
The record links to 10 conditions, with Adult Anaplastic Astrocytoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01119599 reports a single indexed study location in New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT01119599 about?
NCT01119599 is a clinical study titled "RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma". 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/Not...
What is the current status of trial NCT01119599?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2010-05.
What conditions does trial NCT01119599 study?
This clinical trial studies the following conditions: Adult Anaplastic Astrocytoma, Adult Diffuse Astrocytoma, Adult Anaplastic Ependymoma, Adult Brain Stem Glioma, Acoustic Schwannoma.
What interventions are being tested in trial NCT01119599?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Intensity-Modulated Radiation Therapy (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION), Pharmacological Study (OTHER), Gamma-Secretase Inhibitor RO4929097 (DRUG).
Who is sponsoring clinical trial NCT01119599?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01119599 being conducted?
This trial has 2 study locations across New York, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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