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

Kanisa Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Leukemia, Myeloid

Treatments: Drug: gemtuzumab ozogamicin; Drug: Zosuquidar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00233909

KAN-979-02

Details and patient eligibility

About

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.

Full 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)

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)