CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
midostaurin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01093573
NCT01093573Phase 2Completed
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A Phase I/II Study of Midostaurin (PKC412) and 5-Azacitidine for Elderly Patients With Acute Myelogenous Leukemia.

Brenda Cooper, MD·interventional·Posted Mar 26, 2010·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating midostaurin, azacitidine, and 3 other interventions for Untreated Adult Acute Myeloid Leukemia. Completed, enrolled 34 participants across 2 sites.

Detailed Summary

RATIONALE: Midostaurin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Midostaurin may help azacitidine kill more cancer cells by making the cancer cells more sensitive to the drug. PURPOSE: This phase I/II trial is studying the side effects and best dose of midostaurin when given together with azacitidine and to see how well it works in treating elderly patients with acute myelogenous leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUntreated Adult Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 26, 2010
Enrollment StartJul 1, 2009
Primary CompletionSep 8, 2016
Study CompletionMay 5, 2017
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 16.3 years ago

Interventions

midostaurindrug

Given orally

azacitidinedrug

Given IV

bone marrow aspirationother

Correlative study: Pretreatment bone marrow aspirates or blood \[(3 ml in EDTA tube (purple top)\] will be analyzed according to local institution guidelines to determine whether blasts contain wild type Flt3, ITD, or Flt 3 mutations.

mutation analysisother

Correlative study

Pharmacokinetic studyother

Correlative study: Concentrations of unchanged midostaurin and its major metabolites, CGP52421 and CGP62221 in plasma samples will be determined using a validated liquid chromatography / mass spectrometry method.