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CompletedNCT00233909Updated Apr 1, 2008

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

A Phase 1/2 interventional study of Zosuquidar and gemtuzumab ozogamicin in Leukemia, Myeloid, sponsored by Kanisa Pharmaceuticals. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-01.

Sponsored by Kanisa Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
55
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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)

02

Conditions studied

  • Leukemia, Myeloid

Keywords

  • Leukemia, Myeloid
  • Relapse
  • Chemotherapy
  • Zosuquidar
  • gemtuzumab ozogamicin (GO)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 55 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Kanisa Pharmaceuticals is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Interventions

  • DrugZosuquidar
  • Druggemtuzumab ozogamicin
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00233909
Lead sponsor
Kanisa Pharmaceuticals
First posted
Oct 6, 2005
Start date
Oct 2005
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Apr 1, 2008
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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