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Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT ID: NCT00129168

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2008-03-31

Brief Summary

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Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed Description

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Purpose:

Phase I:

To Evaluate the safety of different doses of zosuquidar.

Phase II:

This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

Conditions

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Leukemia, Myeloid

Keywords

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Leukemia, Myeloid Relapse Chemotherapy Zosuquidar Daunorubicin Cytarabine Acute AML Adult AML

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zosuquidar

Intervention Type DRUG

Daunorubicin

Intervention Type DRUG

Cytarabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed acute myeloid leukemia
* Ages 55-75 years

Exclusion Criteria

* Acute promyelocytic leukemia (FAB M3)
* Patients must not have received prior chemotherapy for AML.
* Prior exposure to anthracycline
* Use of any investigational agent within 4 weeks prior to enrollment into the study

For Phase II:

* Patients must be P-glycoprotein positive
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kanisa Pharmaceuticals

INDUSTRY

Sponsor Role lead

Countries

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United States

References

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Marcelletti JF, Sikic BI. Continuous 72-h infusion of zosuquidar with chemotherapy in patients with newly diagnosed acute myeloid leukemia stratified for leukemic blast P-glycoprotein phenotype. Cancer Chemother Pharmacol. 2024 Jun;93(6):595-604. doi: 10.1007/s00280-024-04656-6. Epub 2024 Feb 26.

Reference Type DERIVED
PMID: 38407601 (View on PubMed)

Other Identifiers

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KAN-979-01

Identifier Type: -

Identifier Source: org_study_id