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NCT00916227 · ClinicalTrials.gov registry record · Phase 1

A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome

A Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

Completed
Registry status
Phase 1
Development phase
45
Enrollment target

NCT00916227: Completed Phase 1 study, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

NCT00916227 is a Phase 1 study that has completed, run by Array Biopharma, now a wholly owned subsidiary of Pfizer. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00916227, a Phase 1 study, has completed, sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

Study Summary

This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614. This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 60 patients from the US will be enrolled in Part 1 (Completed). In the second part of this study, patients will receive the best dose of study drug, given either with food or without food, determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 40 patients from the US will be enrolled in Part 2 (Completed).

Interventions

  • DRUG ARRY-614, p38/Tie2 inhibitor; oral

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2009-06
Phase Phase 1

What the finished NCT00916227 record still lists

NCT00916227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 1 intervention - of which ARRY-614, p38/Tie2 inhibitor; oral is the first listed.

NCT00916227 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00916227 about?

NCT00916227 is a clinical study titled "A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome". This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndrome (MDS) will receive investigational study drug ARRY-614. This study has 2 parts. In the first part, patients will receive increasing doses of study drug, given either with food or without food, in ...

What is the current status of trial NCT00916227?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2009-06.

What interventions are being tested in trial NCT00916227?

The interventions under investigation include: ARRY-614, p38/Tie2 inhibitor; oral (DRUG).

Who is sponsoring clinical trial NCT00916227?

This trial is sponsored by Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00916227's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00916227, the US trial registry maintained by the National Library of Medicine. NCT00916227 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.