A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
Phase 1
Completed
- Conditions
- Leukemia, Myeloid
- Registration Number
- NCT00233909
- Lead Sponsor
- Kanisa Pharmaceuticals
- 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.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
- Morphologic evidence of acute myeloid leukemia in first relapse.
- Phase I: 18 years or older, Phase II: 50 years or older
Read More
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
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method