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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: Completed Phase 1 study, sponsored by MediGene.
NCT00157703 is a Phase 1 study that has completed, run by MediGene. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00157703 record still lists
NCT00157703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which G207 is the first listed.
NCT00157703 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00157703's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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