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NCT00858364 · ClinicalTrials.gov registry record · Phase 3
Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
A Phase 3 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,549
- Enrollment target
NCT00858364: Clinical Trial Phase 3 study, sponsored by Amgen.
NCT00858364 is a Phase 3 study that was terminated before completion, run by Amgen. The registered enrollment target is 2,549 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (230% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00858364, a Phase 3 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,549 participants
- Enrollment target
Study Summary
This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.
Primary Outcome
Overall survival (OS) was defined as the time from randomization to the date of death due to any cause. Participants were censored on the date of last contact (ie, the date the participant was last known to be alive) if they were not known to have died.
Interventions
- DRUG Placebo
- DRUG Darbepoetin alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,549 participants |
| Start Date | 2009-07-17 |
| Est. Completion | 2017-06-07 |
| Phase | Phase 3 |
Why NCT00858364 stopped before completion
NCT00858364 is an interventional study that assigns participants to a tested intervention. Its 2,549 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (230% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00858364 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00858364 about?
NCT00858364 is a clinical study titled "Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy". This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated t...
What is the current status of trial NCT00858364?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,549 participants. The study started on 2009-07-17. Estimated completion is 2017-06-07.
What interventions are being tested in trial NCT00858364?
The interventions under investigation include: Placebo (DRUG), Darbepoetin alfa (DRUG).
Who is sponsoring clinical trial NCT00858364?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00858364's enrollment target sits among peer trials
2,549 86th of 2000 higher than 1,915 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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