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NCT00046930 · ClinicalTrials.gov registry record · Phase 3
Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
A Phase 3 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 449
- Enrollment target
NCT00046930: Completed Phase 3 study, sponsored by Eastern Cooperative Oncology Group.
NCT00046930 is a Phase 3 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 449 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046930, a Phase 3 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 449 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia. PURPOSE: This randomized phase III trial is studying how well giving zosuquidar trihydrochloride together with daunorubicin and cytarabine works compared to daunorubicin and cytarabine alone in treating older patients with newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment.
Primary Outcome
Time from randomization to death. Patients alive at last follow-up were censored.
Interventions
- BIOLOGICAL filgrastim
- DRUG cytarabine
- BIOLOGICAL sargramostim
- DRUG daunorubicin hydrochloride
- DRUG zosuquidar trihydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 449 participants |
| Start Date | 2002-09-17 |
| Phase | Phase 3 |
What the finished NCT00046930 record still lists
NCT00046930 is an interventional study that assigns participants to a tested intervention. The registered 449 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 5 interventions - of which filgrastim is the first listed.
NCT00046930 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00046930 about?
NCT00046930 is a clinical study titled "Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia". RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride, a modulator of multidrug resistance (MDR), may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the dr...
What is the current status of trial NCT00046930?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 449 participants. The study started on 2002-09-17.
What interventions are being tested in trial NCT00046930?
The interventions under investigation include: filgrastim (BIOLOGICAL), cytarabine (DRUG), sargramostim (BIOLOGICAL), daunorubicin hydrochloride (DRUG), zosuquidar trihydrochloride (DRUG).
Who is sponsoring clinical trial NCT00046930?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00046930's enrollment target sits among peer trials
449 864th of 2000 higher than 1,137 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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