NCT00233909

Brief Summary

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is 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
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 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

October 1, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2005

Completed
2.4 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

2.4 years

First QC Date

October 4, 2005

Last Update Submit

March 28, 2008

Conditions

Leukemia, Myeloid

Keywords

Leukemia, MyeloidRelapseChemotherapyZosuquidargemtuzumab ozogamicin (GO)

Interventions

ZosuquidarDRUG
gemtuzumab ozogamicinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Morphologic evidence of acute myeloid leukemia in first relapse.
  • Phase I: 18 years or older, Phase II: 50 years or older

You may not qualify if:

  • Prior treatment with zosuquidar
  • Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
  • History of stem cell transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Marcelletti JF, Sikic BI. A clinical trial of zosuquidar plus gemtuzumab ozogamicin (GO) in relapsed or refractory acute myeloid leukemia (RR AML): evidence of efficacy based on leukemic blast P-glycoprotein functional phenotype. Cancer Chemother Pharmacol. 2023 Nov;92(5):369-380. doi: 10.1007/s00280-023-04578-9. Epub 2023 Aug 21.

    PMID: 37603048DERIVED

MeSH Terms

Conditions

Leukemia, MyeloidRecurrence

Interventions

zosuquidar trihydrochlorideGemtuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CalicheamicinsAminoglycosidesGlycosidesCarbohydratesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

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

October 4, 2005

First Posted

October 6, 2005

Study Start

October 1, 2005

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 1, 2008

Record last verified: 2008-03