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NCT00085826 · ClinicalTrials.gov registry record · Phase 3

A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients

A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Astellas Pharma.

Completed
Registry status
Phase 3
Development phase
600
Enrollment target
20
Study locations

NCT00085826: Completed Phase 3 study of Non-Small Cell Lung Cancer, sponsored by Astellas Pharma.

NCT00085826 is a Phase 3 study of Non-Small Cell Lung Cancer that has completed, run by Astellas Pharma. The registered enrollment target is 600 participants, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00085826, a Phase 3 study of Non-Small Cell Lung Cancer, has completed, sponsored by Astellas Pharma.

COMPLETED
Registry status
Phase 3
Development phase
600 participants
Enrollment target
20
Study locations

Study Summary

Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone. This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere. This study has been completed and a publication is pending.

Conditions Studied

Interventions

  • DRUG Exisulind

Study Locations (20)

Colorado

  • Rocky Mountain Cancer Center - Boulder
  • Rocky Mountain Cancer Centers - Colorado Springs
  • RMCC - Denver
  • 12. Rocky Mountain Cancer Centers-Englewood - Englewood
  • Rocky Mountain Cancer Centers - Englewood
  • Rocky Mountain Cancer Centers - Fort Collins
  • Rocky Mountain Cancer Centers - Littleton
  • Rocky Mountain Cancer Centers - Thornton

California

  • Pacific Coast Hematology/Oncology Medical Group, Inc. - Fountain Valley
  • California Cancer Care, Inc. - Greenbrae
  • Scripps Cancer Center - San Diego
  • Sharp Clinical Oncology Research - San Diego
  • Redwood Regional Medical Group - Santa Rosa

Arizona

  • Northern Arizona Hematology and Oncology Associates - Flagstaff
  • Hematology & Oncology Associates - Phoenix
  • Northern Arizona Hematology & Oncology Associates - Sedona
  • Arizona Clinical Research Center - Tucson

Alabama

  • Birmingham Hematology Oncology Associates - Birmingham
  • Birmingham Hematology and Oncology Associates, LLC - Birmingham

Arkansas

  • Arkansas Oncology Associates, PA - Little Rock

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2001-04
Est. Completion 2004-12
Phase Phase 3
Astellas Pharma

165 total trials

What the finished NCT00085826 record still lists

NCT00085826 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target.

The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Exisulind is the first listed.

NCT00085826 names 20 study sites across 5 states, led by Colorado, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT00085826 about?

NCT00085826 is a clinical study titled "A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients". Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged surviva...

What is the current status of trial NCT00085826?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2001-04. Estimated completion is 2004-12.

What conditions does trial NCT00085826 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT00085826?

The interventions under investigation include: Exisulind (DRUG).

Who is sponsoring clinical trial NCT00085826?

This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00085826 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00085826's enrollment target sits among peer trials

600 57th of 454 higher than 396 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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Source: ClinicalTrials.gov NCT00085826, the US trial registry maintained by the National Library of Medicine. NCT00085826 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.