A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

• ClinicalTrials.gov Identifier: NCT00233909
• Recruitment Status: Completed
• First Posted: October 6, 2005
• Last Update Posted: April 1, 2008
• Sponsor: Kanisa Pharmaceuticals
• Information provided by: Kanisa Pharmaceuticals

Tracking Information

• First Submitted Date: October 4, 2005
• First Posted Date: October 6, 2005
• Last Update Posted Date: April 1, 2008
• Study Start Date: October 2005
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00233909 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
• Official Title: An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
• 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)

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Leukemia, Myeloid

Intervention

• Drug: Zosuquidar
• Drug: gemtuzumab ozogamicin

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 5, 2007): 55
• Original Enrollment (submitted: October 4, 2005): 70
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00233909
• Other Study ID Numbers: KAN-979-02
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Kanisa Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Kanisa Pharmaceuticals
• Verification Date: March 2008