- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00233909
A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
March 28, 2008 updated by: Kanisa Pharmaceuticals
An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Purpose:
Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.
Phase II: Determine the complete remission rate (CR+CRp)
Study Type
Interventional
Enrollment (Anticipated)
55
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Morphologic evidence of acute myeloid leukemia in first relapse.
- Phase I: 18 years or older, Phase II: 50 years or older
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
October 4, 2005
First Submitted That Met QC Criteria
October 4, 2005
First Posted (Estimate)
October 6, 2005
Study Record Updates
Last Update Posted (Estimate)
April 1, 2008
Last Update Submitted That Met QC Criteria
March 28, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAN-979-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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