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NCT00096122 · ClinicalTrials.gov registry record · Phase 1
Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT00096122: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00096122 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096122, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Tipifarnib (Zarnestra) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Giving idarubicin and cytarabine with tipifarnib may kill more cancer cells.
Primary Outcome
Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1\*10\^9/L or more and platelet count of 100\*10\^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20\*10\^9/L to less than 100\*10\^9/L.
Interventions
- DRUG cytarabine
- DRUG idarubicin
- DRUG tipifarnib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2004-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT00096122 record still lists
NCT00096122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 3 interventions - of which cytarabine is the first listed.
NCT00096122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00096122 about?
NCT00096122 is a clinical study titled "Idarubicin, Cytarabine, and Tipifarnib in Treating Patients With Newly Diagnosed Myelodysplastic Syndromes or Acute Myeloid Leukemia". This phase I/II trial is studying the side effects and best dose of tipifarnib when given with idarubicin and cytarabine and to see how well it works in treating patients with newly diagnosed myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy, such as idarubicin and cyta...
What is the current status of trial NCT00096122?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2004-09. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00096122?
The interventions under investigation include: cytarabine (DRUG), idarubicin (DRUG), tipifarnib (DRUG).
Who is sponsoring clinical trial NCT00096122?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00096122's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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