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

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).

Completed

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) of 0, 1 or 2.
Adequate liver and renal function.
Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

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.
Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
Additional criteria exist.

Treatment and study plan

ARRY-614, p38/Tie2 inhibitor; oral

Drug

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

Primary outcomes

Establish the maximum tolerated dose (MTD) of study drug.

Time frame: Part 1, 9 months
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

Time frame: Part 1, 9 months; Part 2, 9 months
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.

Time frame: Part 1, 9 months; Part 2, 9 months

Secondary outcomes

Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.

Time frame: Part 1, 9 months; Part 2, 9 months

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Dec 21, 2011
Registry last updated: Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed