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NCT00636805 · ClinicalTrials.gov registry record · Phase 2
Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00636805: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT00636805 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00636805, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
1. Primary Objective: * To determine the efficacy and tolerability of palonosetron and dexamethasone in preventing acute CINV in brain tumor patients during the first 24 hours of receiving Irinotecan /Bevacizumab regimens. 2. Secondary Objective * To determine the safety and tolerability of palonosetron in brain tumor patients. * To determine the effects of glucocorticoid and anticonvulsants on the efficacy of palonosetron. * To determine the efficacy of palonosetron and dexamethasone in preventing delayed CINV in brain tumor patients during days 2-5. * To determine if patients receiving palonosetron have less fatigue than baseline.
Primary Outcome
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Interventions
- DRUG Palonosetron (Aloxi) and Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-05 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
Why NCT00636805 stopped before completion
NCT00636805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Palonosetron (Aloxi) and Dexamethasone is the first listed.
NCT00636805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00636805 about?
NCT00636805 is a clinical study titled "Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab". 1. Primary Objective: * To determine the efficacy and tolerability of palonosetron and dexamethasone in preventing acute CINV in brain tumor patients during the first 24 hours of receiving Irinotecan /Bevacizumab regimens. 2. Secondary Objective * To determine the safety and tolerability of ...
What is the current status of trial NCT00636805?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2008-05. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00636805?
The interventions under investigation include: Palonosetron (Aloxi) and Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT00636805?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00636805's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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