Back to resultsA Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Primary Purpose
Myelodysplastic Syndromes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARRY-614, p38/Tie2 inhibitor; oral
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Low or Intermediate-1 Risk Myelodysplastic Syndrome
Eligibility Criteria
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.
Sites / Locations
- Moffitt Cancer Center
- Winship Cancer Institute
- MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARRY-614
Arm Description
Outcomes
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.
Establish the maximum tolerated dose (MTD) of the study drug.
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
Secondary Outcome Measures
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
Full Information
NCT ID
NCT00916227
First Posted
June 3, 2009
Last Updated
September 4, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00916227
Brief Title
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Low or Intermediate-1 Risk Myelodysplastic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARRY-614
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ARRY-614, p38/Tie2 inhibitor; oral
Intervention Description
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Primary Outcome Measure Information:
Title
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.
Time Frame
Part 1, one year; Part 2, one year
Title
Establish the maximum tolerated dose (MTD) of the study drug.
Time Frame
Part 1, one year
Title
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
Time Frame
Part 1, one year; Part 2, one year
Secondary Outcome Measure Information:
Title
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
Time Frame
Part 1, one year; Part 2, one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
We'll reach out to this number within 24 hrs