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NCT00108056 · ClinicalTrials.gov registry record · Phase 1
Enzastaurin to Treat Recurrent Brain Tumor
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00108056: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00108056 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00108056, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study will examine the safety of a twice-a-day dosing regimen of the experimental drug Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood vessels that tumors need to grow. It has shown some effect against brain tumors in animals and in some patients with recurrent gliomas. This study will see if the drug can help patients with gliomas and how much drug they should be given. Patients 18 years of age and older with malignant glioma that has recurred after standard therapy may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, magnetic resonance imaging (MRI) or computed tomography (CT) scans, and an electrocardiogram. Participants are divided into two groups of patients-those who are and those who are not taking certain anti-seizure medications-in order to determine if the anti-seizure medication alters the way the body handles Enzastaurin. Patients in both groups are further divided into different dosing regimens: some in each group take Enzastaurin once a day for 3 weeks, followed by twice a day for 3 weeks; others in the group take the drug twice a day for 3 weeks followed by once a day for 3 weeks. The medication is taken by mouth every day. Treatment is given in 6-week cycles and may continue for 1 year unless the tumor grows or the patient develops unacceptable drug side effects. In addition to drug treatment, patients have the following tests and procedures: * Medical history, physical, and neurological examinations every 3 weeks during the first cycle and then every 6 weeks. * MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides int
Interventions
- DRUG Enzastaurin (LY317615) monohydronchloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2005-04-07 |
| Est. Completion | 2014-04-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00108056
The ClinicalTrials.gov registry entry for NCT00108056 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enzastaurin (LY317615) monohydronchloride is the first listed.
NCT00108056 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00108056 about?
NCT00108056 is a clinical study titled "Enzastaurin to Treat Recurrent Brain Tumor". This study will examine the safety of a twice-a-day dosing regimen of the experimental drug Enzastaurin in patients with malignant glioma (a cancerous brain tumor) who are and who are not taking certain anti-seizure medicines. Enzastaurin may prevent the formation of new blood vessels that tumors ne...
What is the current status of trial NCT00108056?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2005-04-07. Estimated completion is 2014-04-01.
What interventions are being tested in trial NCT00108056?
The interventions under investigation include: Enzastaurin (LY317615) monohydronchloride (DRUG).
Who is sponsoring clinical trial NCT00108056?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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