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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 69 participants.

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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.

Interventions

  • DRUG cytarabine
  • DRUG daunorubicin hydrochloride
  • DRUG midostaurin

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2004-02
Est. Completion 2011-06
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00093600

The ClinicalTrials.gov registry entry for NCT00093600 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which cytarabine is the first listed.

NCT00093600 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.