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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01496495
First received: November 28, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 (Active, not recruiting).

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 (Active, not recruiting).


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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: Part 1, 9 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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. [ Time Frame: Part 1, 9 months; Part 2, 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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) 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496495

Locations
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01496495     History of Changes
Other Study ID Numbers: ARRAY-614-112
Study First Received: November 28, 2011
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014