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Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia

NCT01093573 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-06-30

Study results available
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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.

Conditions

  • Untreated Adult Acute Myeloid Leukemia

Interventions

DRUG

midostaurin

Given orally

DRUG

azacitidine

Given IV

OTHER

bone marrow aspiration

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.

OTHER

mutation analysis

Correlative study

OTHER

Pharmacokinetic study

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Brenda Cooper, MD

    lead OTHER

Principal Investigators

  • Brenda Cooper, MD · Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2016-09-08
Completion
2017-05-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01093573 on ClinicalTrials.gov