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NCT00540514 · ClinicalTrials.gov registry record · Phase 3
Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer
A Phase 3 study of Non-Small-Cell Lung Carcinoma, sponsored by Celgene.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,052
- Enrollment target
- 20
- Study locations
NCT00540514: Completed Phase 3 study of Non-Small-Cell Lung Carcinoma, sponsored by Celgene.
NCT00540514 is a Phase 3 study of Non-Small-Cell Lung Carcinoma that has completed, run by Celgene. The registered enrollment target is 1,052 participants, above the 201-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (423% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00540514, a Phase 3 study of Non-Small-Cell Lung Carcinoma, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,052 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
Primary Outcome
Antitumor response was defined as the percentage of participants who achieved an objective response (Confirmed Response \[CR\] or Partial Response \[PR\]), confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. Response was based on the blinded radiological review using Response Evaluation Criteria in Solid Tumors (RECIST) response guidelines, Version 1.0. A complete response was defined as a disappearance of all target and non-target lesi
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- DRUG Albumin-bound paclitaxel
Study Locations (20)
California
- Pacific Cancer Medical Center, Inc. - Anaheim
- Comprehensive Blood and Cancer Center - Bakersfield
- Southwest Cancer Care - Escondido
- Robert A. Moss, MD, FACP, Inc. - Fountain Valley
- Pacific Shores Medical Group - Long Beach
- Ventura County Hematology-Oncology Specialists - Oxnard
- Comprehensice Cancer Ctr. - Palms Springs
Arkansas
- Genesis Cancer Center- Hot Springs - Hot Springs
- Little Rock Hematology Oncology Associates - Little Rock
Florida
- Gulf Coast Oncology Associates - St. Petersburg
- Lake County Oncology and Hematology, PA - Tavares
Maine
- Mercy Hospital - Portland
- Maine Center for Cancer Medicine - Scarborough
Alabama
- Clearview Cancer Institute Oncology Specialties, P.C. - Huntsville
Georgia
- Phoebe Cancer Center - Albany
Kansas
- Cancer Center of Kansas - Wichita
Kentucky
- Kentuckiana Cancer Institute, PLLC - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,052 participants |
| Start Date | 2007-11-01 |
| Est. Completion | 2013-02-01 |
| Phase | Phase 3 |
What the finished NCT00540514 record still lists
NCT00540514 is an interventional study that assigns participants to a tested intervention. Its 1,052 participants enrollment target places it among the larger protocols in the corpus, above the 201-participant average among 30 other Non-Small-Cell Lung Carcinoma trials with a reported enrollment target (423% higher).
The record links to 1 condition, with Non-Small-Cell Lung Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT00540514 names 20 study sites across 11 states, led by California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT00540514 about?
NCT00540514 is a clinical study titled "Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer". The purpose of this study is to compare disease response of Albumin-bound paclitaxel (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC).
What is the current status of trial NCT00540514?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,052 participants. The study started on 2007-11-01. Estimated completion is 2013-02-01.
What conditions does trial NCT00540514 study?
This clinical trial studies the following conditions: Non-Small-Cell Lung Carcinoma.
What interventions are being tested in trial NCT00540514?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Albumin-bound paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00540514?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00540514 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00540514's enrollment target sits among peer trials
1,052 2nd of 30 the highest of 30 other Non-Small-Cell Lung Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small-Cell Lung Carcinoma 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.
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