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NCT00361842 · ClinicalTrials.gov registry record · Phase 2
Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
NCT00361842: Completed Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT00361842 is a Phase 2 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00361842, a Phase 2 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.
Primary Outcome
Disease response was assessed using RECIST 1.0. Measurable disease and target lesions were determined prior to study entry. Changes in the largest diameter (unidimensional measurement) of the sum of the target tumor lesions were used in the RECIST criteria. Best response on study was classified as follows. Complete Response (CR), disappearance of all clinical and radiological evidence of tumor. Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions tak
Interventions
- DRUG CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00361842 record still lists
NCT00361842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 1 intervention - of which CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection is the first listed.
NCT00361842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00361842 about?
NCT00361842 is a clinical study titled "Multicenter Study Of CPX-1 (Irinotecan HCl: Floxuridine) Liposome Injection In Patients With Advanced Colorectal Cancer". The purpose of this study is to determine whether CPX-1 is effective in patients with advanced colorectal cancer who have already received chemotherapy that included the drug oxaliplatin or irinotecan. All patients will receive CPX-1 at a dose of 210 units/m2 over 90 minutes every two weeks.
What is the current status of trial NCT00361842?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2006-07. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00361842?
The interventions under investigation include: CPX-1 (Irinotecan HCl:Floxuridine) Liposome Injection (DRUG).
Who is sponsoring clinical trial NCT00361842?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00361842's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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