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

Primary Purpose

Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARRY-614, p38/Tie2 inhibitor; oral
Sponsored by
Array Biopharma, now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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) of 0, 1 or 2.
  • Adequate liver and renal function.
  • Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

  • History of bone marrow transplant.
  • Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug.
  • 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 prolonged side effects.
  • Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug.
  • Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug.
  • Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug.
  • Additional criteria exist.

Sites / Locations

  • Moffitt Cancer Center
  • Emory University, Winship Cancer Institute
  • Cleveland Clinic
  • MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARRY-614

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 28, 2011
Last Updated
September 4, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01496495
Brief Title
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 18, 2015 (Actual)

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (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
Establish the maximum tolerated dose (MTD) of study drug.
Time Frame
Part 1, 9 months
Title
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame
Part 1, 9 months; Part 2, 9 months
Title
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Time Frame
Part 1, 9 months; Part 2, 9 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
Part 1, 9 months; Part 2, 9 months

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) of 0, 1 or 2. Adequate liver and renal function. Additional criteria exist. Key Exclusion Criteria (Part 1 and Part 2): History of bone marrow transplant. Treatment for MDS other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug. 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 prolonged side effects. Treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug. Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to > 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug. Treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug. 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
Emory University, Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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

Citations:
PubMed Identifier
34320342
Citation
Su H, Jiang M, Senevirathne C, Aluri S, Zhang T, Guo H, Xavier-Ferrucio J, Jin S, Tran NT, Liu SM, Sun CW, Zhu Y, Zhao Q, Chen Y, Cable L, Shen Y, Liu J, Qu CK, Han X, Klug CA, Bhatia R, Chen Y, Nimer SD, Zheng YG, Iancu-Rubin C, Jin J, Deng H, Krause DS, Xiang J, Verma A, Luo M, Zhao X. Methylation of dual-specificity phosphatase 4 controls cell differentiation. Cell Rep. 2021 Jul 27;36(4):109421. doi: 10.1016/j.celrep.2021.109421.
Results Reference
derived

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

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