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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916227
First Posted: June 9, 2009
Last Update Posted: December 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Array BioPharma
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

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. [ Time Frame: Part 1, one year; Part 2, one year ]
  • Establish the maximum tolerated dose (MTD) of the study drug. [ Time Frame: Part 1, one year ]
  • 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 Measures:
  • 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 ]

Enrollment: 45
Study Start Date: June 2009
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-614 Drug: ARRY-614, p38/Tie2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916227


Locations
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Array BioPharma
  More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00916227     History of Changes
Other Study ID Numbers: ARRAY-614-111
First Submitted: June 3, 2009
First Posted: June 9, 2009
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Array BioPharma:
Low or Intermediate-1 Risk Myelodysplastic Syndrome

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms