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NCT00382720 · ClinicalTrials.gov registry record · Phase 2
Docetaxel and Oxaliplatin in Gastric Cancer
A Phase 2 study of Stomach Neoplasms, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
- 12
- Study locations
NCT00382720 is a Phase 2 study of Stomach Neoplasms that has completed, run by Sanofi. The registered enrollment target is 275 participants, roughly in line with the 281-participant average among 10 other Stomach Neoplasms trials with a reported enrollment target. The trial reports 12 study locations across 2 states.
The verdict
NCT00382720, a Phase 2 study of Stomach Neoplasms, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal dose by assessing the safety and tolerability of 2 dose levels in each arm. The optimal dose was administered in the Part II study. Participants who received the optimal dose in each treatment arm in Part I were included in the Part II analysis population. Primary objective: * To assess the time to progression (TTP) of Docetaxel in combination with Oxaliplatin with or without 5-Fluorouracil (5-FU) or Capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease (part II). Secondary objectives: * To establish the safety profile. * To assess the Overall Response Rate (ORR) based on the World Health Organization (WHO) criteria * To assess the Overall Survival (OS)
Conditions Studied
Interventions
- DRUG Docetaxel + Oxaliplatin
- DRUG Docetaxel + Oxaliplatin + 5-FU
- DRUG Docetaxel + Oxaliplatin + Capecitabine
Study Locations (12)
Other
- Sanofi-Aventis Administrative Office - Diegem
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Frankfurt
- Sanofi-Aventis Administrative Office - Budapest
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Porto Salvo
- Sanofi-Aventis Administrative Office - Moscow
- Sanofi-Aventis Administrative Office - Barcelona
- Sanofi-Aventis Administrative Office - Geneva
- Sanofi-Aventis Administrative Office - Istanbul
- Sanofi-Aventis Administrative Office - Guildford Surrey
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00382720
The ClinicalTrials.gov registry entry for NCT00382720 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 281-participant average among 10 other Stomach Neoplasms trials with a reported enrollment target. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stomach Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel + Oxaliplatin is the first listed.
NCT00382720 reports 12 study locations spanning 2 distinct geographic areas - top geographies include Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00382720 about?
NCT00382720 is a clinical study titled "Docetaxel and Oxaliplatin in Gastric Cancer". This phase II study addressed the use of docetaxel in combination with oxaliplatin with or without 5-FU or capecitabine in metastatic or locally recurrent gastric cancer previously untreated with chemotherapy for advanced disease. Prior to this study a pilot phase I (part I) determined the optimal d...
What is the current status of trial NCT00382720?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2006-09. Estimated completion is 2010-04.
What conditions does trial NCT00382720 study?
This clinical trial studies the following conditions: Stomach Neoplasms.
What interventions are being tested in trial NCT00382720?
The interventions under investigation include: Docetaxel + Oxaliplatin (DRUG), Docetaxel + Oxaliplatin + 5-FU (DRUG), Docetaxel + Oxaliplatin + Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00382720?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00382720 being conducted?
This trial has 12 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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