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

This study has been completed.
Sponsor:
Information provided by:
Kanisa Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00233909
First received: October 4, 2005
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Leukemia, Myeloid
Drug: Zosuquidar
Drug: gemtuzumab ozogamicin
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Kanisa Pharmaceuticals:

Estimated Enrollment: 55
Study Start Date: October 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233909     History of Changes
Other Study ID Numbers: KAN-979-02
Study First Received: October 4, 2005
Last Updated: March 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Kanisa Pharmaceuticals:
Leukemia, Myeloid
Relapse
Chemotherapy
Zosuquidar
gemtuzumab ozogamicin (GO)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Gemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014