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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 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.
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
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00916227
The ClinicalTrials.gov registry entry for NCT00916227 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Array Biopharma, now a wholly owned subsidiary of Pfizer, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ARRY-614, p38/Tie2 inhibitor; oral is the first listed.
NCT00916227 reports 0 study locations.
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.
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