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

NCT00916227 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-09-09

No results posted yet for this 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).

Conditions

Interventions

DRUG

ARRY-614, p38/Tie2 inhibitor; oral

Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

Sponsors & Collaborators

  • Array Biopharma, now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00916227 on ClinicalTrials.gov