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

Phase 1

Completed

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: ARRY-614, p38/Tie2 inhibitor; oral

• Registration Number: NCT00916227
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-03
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-09
• Primary Completion: 2012-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARRY-614	ARRY-614, p38/Tie2 inhibitor; oral	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (3)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States