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

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00916227

Collaborator

(none)

Enrollment

Locations

Arm

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Drug: ARRY-614, p38/Tie2 inhibitor; oral	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ARRY-614

Drug: ARRY-614, p38/Tie2 inhibitor; oral

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	Winship Cancer Institute	Atlanta	Georgia	United States	30322
3	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

Array Biopharma, now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Array Biopharma, now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00916227

Other Study ID Numbers:

ARRAY-614-111

First Posted:

Jun 9, 2009

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Keywords provided by Array Biopharma, now a wholly owned subsidiary of Pfizer

Low or Intermediate-1 Risk Myelodysplastic Syndrome

Additional relevant MeSH terms:

Preleukemia

Myelodysplastic Syndromes

Syndrome

Study Results

No Results Posted as of Sep 9, 2020