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NCT00157703 · ClinicalTrials.gov registry record · Phase 1
G207 Followed by Radiation Therapy in Malignant Glioma
A Phase 1 study, sponsored by MediGene.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00157703 is a Phase 1 study that has completed, run by MediGene. The registered enrollment target is 9 participants.
The verdict
NCT00157703, a Phase 1 study, has completed, sponsored by MediGene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This is an open-label, single site study to evaluate the safety and tolerability of intratumoral administration of G207 followed by treatment with radiation therapy in patients with recurrent/progressive malignant glioma. This study is a two stage phase 1 study, in which a de-escalating dosing scheme will be used, i.e. the first patients will receive the higher dose and if excessive toxicity occurs, the dose will be reduced for the following patients. The purpose of the dose de-escalation phase is to find the best safe dose of G207. In the first stage of the study, treatment with G207 will be followed by focal radiation therapy on the following day, and in the second stage treatment with G207 will be followed by gamma knife surgery also on the following day. All patients will return to the clinic 28 days and 3, 6, 9 and 12 months after G207 administration at which time clinical assessments will be performed, and will be followed for safety and survival at clinic visits or by telephone every 3 months for up to 2 additional years and annually thereafter.
Interventions
- DRUG G207
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2005-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00157703
The ClinicalTrials.gov registry entry for NCT00157703 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediGene, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which G207 is the first listed.
NCT00157703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00157703 about?
NCT00157703 is a clinical study titled "G207 Followed by Radiation Therapy in Malignant Glioma". This is an open-label, single site study to evaluate the safety and tolerability of intratumoral administration of G207 followed by treatment with radiation therapy in patients with recurrent/progressive malignant glioma. This study is a two stage phase 1 study, in which a de-escalating dosing sche...
What is the current status of trial NCT00157703?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2005-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00157703?
The interventions under investigation include: G207 (DRUG).
Who is sponsoring clinical trial NCT00157703?
This trial is sponsored by MediGene, which has 3 total clinical trials registered on ClinicalTrials.gov.
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