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NCT00305188 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 879
- Enrollment target
NCT00305188 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 879 participants.
The verdict
NCT00305188, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 879 participants
- Enrollment target
Study Summary
Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).
Interventions
- DRUG Placebo
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
- DRUG Xaliproden (SR57746A)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 879 participants |
| Start Date | 2005-12 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00305188
The ClinicalTrials.gov registry entry for NCT00305188 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 879 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00305188 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00305188 about?
NCT00305188 is a clinical study titled "Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.". Primary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in ...
What is the current status of trial NCT00305188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 879 participants. The study started on 2005-12. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00305188?
The interventions under investigation include: Placebo (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG), Xaliproden (SR57746A) (DRUG).
Who is sponsoring clinical trial NCT00305188?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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