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

Phase 1

Completed

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

• Registration Number: NCT01496495
• 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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-28
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-21
• Study Start: 2012-01
• Primary Completion: 2014-12
• Study Completion: 2015-03-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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
Establish the maximum tolerated dose (MTD) of study drug.	Part 1, 9 months
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.	Part 1, 9 months; Part 2, 9 months
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.	Part 1, 9 months; Part 2, 9 months

Secondary Outcome Measures

Name	Time	Method
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.	Part 1, 9 months; Part 2, 9 months

Trial Locations

Locations (4)

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

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

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

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States