NCT00129168

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2005

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

2.6 years

First QC Date

August 9, 2005

Last Update Submit

March 28, 2008

Conditions

Leukemia, Myeloid

Keywords

Leukemia, MyeloidRelapseChemotherapyZosuquidarDaunorubicinCytarabineAcuteAMLAdult AML

Interventions

ZosuquidarDRUG
DaunorubicinDRUG
CytarabineDRUG

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38407601DERIVED

MeSH Terms

Conditions

Leukemia, MyeloidRecurrenceLeukemia, Myeloid, Acute

Interventions

zosuquidar trihydrochlorideDaunorubicinCytarabine

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 11, 2005

Study Start

August 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 1, 2008

Record last verified: 2008-03