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NCT01567059 · ClinicalTrials.gov registry record · Phase 2

Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target

NCT01567059: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

NCT01567059 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01567059, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

This study examines a new oral chemotherapy drug called tosedostat, in combination with cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in early studies to have activity against a variety of cancers, including leukemias. Patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) with specific genetic mutations have a poorer response to chemotherapy and a higher risk of relapse after treatment. Researchers are looking to see if combinations of chemotherapy drugs may improve outcomes for patients that do not respond as well with the current chemotherapy regimens, without increasing the risks of treatment.

Primary Outcome

Defined by Cheson et al.

Interventions

  • DRUG decitabine
  • DRUG cytarabine
  • DRUG tosedostat

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2012-05
Est. Completion 2013-06
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

What the finished NCT01567059 record still lists

NCT01567059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 3 interventions - of which decitabine is the first listed.

NCT01567059 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01567059 about?

NCT01567059 is a clinical study titled "Tosedostat in Combination With Cytarabine or Decitabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome". This study examines a new oral chemotherapy drug called tosedostat, in combination with cytarabine or decitabine. Tosedostat is thought to work by decreasing the availability of amino acids (building blocks the cell needs to make proteins) in cells. It has been shown in early studies to have activit...

What is the current status of trial NCT01567059?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2012-05. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01567059?

The interventions under investigation include: decitabine (DRUG), cytarabine (DRUG), tosedostat (DRUG).

Who is sponsoring clinical trial NCT01567059?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01567059's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01567059, the US trial registry maintained by the National Library of Medicine. NCT01567059 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.