CClinicalTrials.gg
Sign In
CompletedNCT00129168Updated Apr 1, 2008

Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

A Phase 1/2 interventional study of Zosuquidar and Daunorubicin in Leukemia, Myeloid, sponsored by Kanisa Pharmaceuticals. Completed. Open to participants aged 55 Years to 75 Years. 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
100
Allocation
Non-randomized
Ages
55 Years to 75 Years
Sex
All
01

Study summary

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Read the detailed description

Purpose:

Phase I:

To Evaluate the safety of different doses of zosuquidar.

Phase II:

This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

02

Conditions studied

  • Leukemia, Myeloid

Keywords

  • Leukemia, Myeloid
  • Relapse
  • Chemotherapy
  • Zosuquidar
  • Daunorubicin
  • Cytarabine
  • Acute
  • AML
  • Adult AML
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 100 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
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Newly diagnosed acute myeloid leukemia
  • Ages 55-75 years

Exclusion criteria

Exclusion Criteria:

  • Acute promyelocytic leukemia (FAB M3)
  • Patients must not have received prior chemotherapy for AML.
  • Prior exposure to anthracycline
  • Use of any investigational agent within 4 weeks prior to enrollment into the study

For Phase II:

  • Patients must be P-glycoprotein positive
05

Study design

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

Interventions

  • DrugZosuquidar
  • DrugDaunorubicin
  • DrugCytarabine
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
NCT00129168
Lead sponsor
Kanisa Pharmaceuticals
First posted
Aug 11, 2005
Start date
Aug 2005
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Apr 1, 2008
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

Kanisa Pharmaceuticals

Start the discussion