Completed

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

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What is being tested

ARRY-614, p38/Tie2 inhibitor; oral

Drug
Who is being recruted

Bone Marrow Diseases+1

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2012
See protocol details

Summary

Principal SponsorArray Biopharma, now a wholly owned subsidiary of Pfizer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2012

Actual date on which the first participant was enrolled.

This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (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 in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose of study drug 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 30 patients from the US will be enrolled in Part 2 (Completed).

Official TitleA Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
NCT01496495
Principal SponsorArray Biopharma, now a wholly owned subsidiary of Pfizer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

71 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesMyelodysplastic Syndromes

Criteria

8 exclusion criteria prevent from participating
History of bone marrow transplant.
Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
Concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment.
Treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have prolonged side effects.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Moffitt Cancer Center

Tampa, United StatesOpen Moffitt Cancer Center in Google Maps
Suspended

Emory University, Winship Cancer Institute

Atlanta, United States
Suspended

Cleveland Clinic

Cleveland, United States
Suspended

MD Anderson Cancer Center

Houston, United States
Completed4 Study Centers