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NCT00093600 · ClinicalTrials.gov registry record · Phase 1
PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT00093600: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00093600 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 69 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00093600, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study Summary
RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining PKC412 with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when given either after or together with daunorubicin and cytarabine in treating patients with newly diagnosed acute myeloid leukemia.
Primary Outcome
cycle = between 28 days and 42 days in duration
Interventions
- DRUG cytarabine
- DRUG daunorubicin hydrochloride
- DRUG midostaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2004-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT00093600 record still lists
NCT00093600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% higher).
The record links to 0 conditions, and to 3 interventions - of which cytarabine is the first listed.
NCT00093600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00093600 about?
NCT00093600 is a clinical study titled "PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia". RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in...
What is the current status of trial NCT00093600?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2004-02. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00093600?
The interventions under investigation include: cytarabine (DRUG), daunorubicin hydrochloride (DRUG), midostaurin (DRUG).
Who is sponsoring clinical trial NCT00093600?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00093600's enrollment target sits among peer trials
69 774th of 2000 higher than 1,225 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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