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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARRY-614

Group Type EXPERIMENTAL

ARRY-614, p38/Tie2 inhibitor; oral

Intervention Type DRUG

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

Interventions

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ARRY-614, p38/Tie2 inhibitor; oral

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of MDS by bone marrow biopsy.
* International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS.
* May have received prior therapy for MDS.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
* Adequate liver and renal function.
* Additional criteria exist.

Exclusion Criteria

* History of bone marrow transplant.
* 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 late side effects.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis C and/or active hepatitis B.
* Additional criteria exist.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No