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NCT01316809 · ClinicalTrials.gov registry record · Phase 1
AZD8055 for Adults With Recurrent Gliomas
A Phase 1 study of Glioblastoma Multiforme and Malignant Glioma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT01316809: Completed Phase 1 study of Glioblastoma Multiforme and Malignant Glioma, sponsored by National Cancer Institute (NCI).
NCT01316809 is a Phase 1 study of Glioblastoma Multiforme and Malignant Glioma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 22 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316809, a Phase 1 study of Glioblastoma Multiforme and Malignant Glioma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- AZD8055 is an experimental cancer treatment drug that works by inhibiting a protein called mTOR, which is known to promote tumor cell and blood vessel growth and to control tumor s energy and nutrient levels. AZD8055 is the first drug that inhibits both types of mTOR protein and is expected to be more effective than prior mTOR inhibitors. However, more research is needed to determine its safety and effectiveness in treating brain tumors known as gliomas that have not responded to standard treatments. Objectives: \- To evaluate the safety and effectiveness of AZD8055 in individuals with gliomas that have not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with gliomas that have not responded to standard chemotherapy, surgery, or radiation. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants will be separated into two treatment groups: one group that will receive surgery to remove the glioma and one that will not have surgical treatment. * Participants in the nonsurgical treatment group will take AZD8055 by mouth daily for a 42-day cycle of treatment. Participants will keep a diary to record doses and keep track of any side effects. * Participants in the surgical treatment group will take AZD8055 by mouth daily for 7 days, and then will have tumor removal surgery. At least 3 weeks after surgery, participants will resume doses of AZD8055 and will continue to take the drug for as long as the tumor does not recur. * During treatment, participants will have regular visits to the clinical center, involving frequent blood and urine tests and other examinations to monitor the effects of treatment. Participants will have imaging studies to study the cancer's response to the treatment. * Participants will continue to have cycles of treatment for as long as the treatment continues to be effective and the si
Conditions Studied
Interventions
- DRUG AZD8055
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-03-04 |
| Est. Completion | 2016-04-04 |
| Phase | Phase 1 |
What the finished NCT01316809 record still lists
NCT01316809 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 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (77% lower).
The record links to 5 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which AZD8055 is the first listed.
NCT01316809 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01316809 about?
NCT01316809 is a clinical study titled "AZD8055 for Adults With Recurrent Gliomas". Background: \- AZD8055 is an experimental cancer treatment drug that works by inhibiting a protein called mTOR, which is known to promote tumor cell and blood vessel growth and to control tumor s energy and nutrient levels. AZD8055 is the first drug that inhibits both types of mTOR protein and is e...
What is the current status of trial NCT01316809?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-03-04. Estimated completion is 2016-04-04.
What conditions does trial NCT01316809 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Malignant Glioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Brainstem Glioma.
What interventions are being tested in trial NCT01316809?
The interventions under investigation include: AZD8055 (DRUG).
Who is sponsoring clinical trial NCT01316809?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01316809 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01316809's enrollment target sits among peer trials
22 68th of 88 higher than 20 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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