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

NCT00916227 | Completed Phase 1

• 1 other identifier: ARRAY-614-111
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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).

Conditions

Myelodysplastic Syndromes

Keywords

Low or Intermediate-1 Risk Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.

  Part 1, one year; Part 2, one year

Study Arms (1)

ARRY-614

EXPERIMENTAL

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

Interventions

ARRY-614, p38/Tie2 inhibitor; oral DRUG

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

ARRY-614

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

pexmetinib

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 9, 2009
• Study Start: June 1, 2009
• Primary Completion: January 1, 2012
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

US (3)