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NCT00866281 · ClinicalTrials.gov registry record · Phase 1

A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
22
Enrollment target

NCT00866281 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 22 participants.

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The verdict

NCT00866281, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
22 participants
Enrollment target

Study Summary

This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, including MLL-rearranged ALL and FLT3 positive AML.

Interventions

  • DRUG midostaurin

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2009-09
Est. Completion 2014-09
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT00866281

The ClinicalTrials.gov registry entry for NCT00866281 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 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 1 intervention - of which midostaurin is the first listed.

NCT00866281 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00866281 about?

NCT00866281 is a clinical study titled "A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia". This is a phase I/II pediatric dose-ranging study that will evaluate the safety, tolerability, clinical response, pharmacokinetics and pharmacodynamics of midostaurin in patients \<18 years of age who have relapsed or refractory acute leukemias that may benefit from administration of midostaurin, in...

What is the current status of trial NCT00866281?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-09. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00866281?

The interventions under investigation include: midostaurin (DRUG).

Who is sponsoring clinical trial NCT00866281?

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.