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NCT01445119 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent Gliomas
A Phase 1 study of Recurrent Gliomas, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT01445119: Completed Phase 1 study of Recurrent Gliomas, sponsored by Eli Lilly and Company.
NCT01445119 is a Phase 1 study of Recurrent Gliomas that has completed, run by Eli Lilly and Company. The registered enrollment target is 58 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01445119, a Phase 1 study of Recurrent Gliomas, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and accumulation, requiring a blood supply. Research shows that brain tumor cells can produce substances that stimulate new blood vessel formation. This study will look into whether the combination of drugs can stop that process. Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast feeding, and who do not have serious diseases may be eligible for this study. About 96 patients will participate for 1 year. They will have a physical examination, give blood and urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to distinguish a live tumor from a dying one. Researchers are studying patients taking a certain type of antiseizure medicine and patients who are not taking it because some antiseizure medicines may change the way the body handles a drug such as Enzastaurin. There will be two groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12 patients at each level. Patients' doctors will tell them which group they belong to and how much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and neurological examinations are repeated at the e
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Enzastaurin (LY317615)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT01445119 record still lists
NCT01445119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Recurrent Gliomas appearing as the primary indexed condition, and to 2 interventions - of which Carboplatin is the first listed.
NCT01445119 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01445119 about?
NCT01445119 is a clinical study titled "A Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent Gliomas". This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of cancers, though not recurren...
What is the current status of trial NCT01445119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2007-01. Estimated completion is 2013-07.
What conditions does trial NCT01445119 study?
This clinical trial studies the following conditions: Recurrent Gliomas.
What interventions are being tested in trial NCT01445119?
The interventions under investigation include: Carboplatin (DRUG), Enzastaurin (LY317615) (DRUG).
Who is sponsoring clinical trial NCT01445119?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01445119 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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