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

Leukemia, Myeloid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233909
• Other study ID #: KAN-979-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 4, 2005
• Last updated: March 28, 2008
• Start date: October 2005
• Est. completion date: March 2008

Study information

• Verified date: March 2008
• Source: Kanisa Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Zosuquidar

• gemtuzumab ozogamicin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kanisa Pharmaceuticals