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 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).

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Drug: ARRY-614, p38/Tie2 inhibitor; oral

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria (Part 1 and Part 2):

• 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.

Key Exclusion Criteria (Part 1 and Part 2):

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARRY-614	Drug: ARRY-614, p38/Tie2 inhibitor; oral; Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.	Part 1, one year
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.	Part 1, one year; Part 2, one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.	Part 1, one year; Part 2, one year

Collaborators and Investigators

• Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Low or Intermediate-1 Risk Myelodysplastic Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: ARRAY-614-111