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

November 28, 2011
September 27, 2013
January 2012
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01496495 on ClinicalTrials.gov Archive Site
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 ]
Assess the efficacy of the study drug in terms of response, time to response, duration of response, hematologic improvement and platelet transfusion independence/reduction. [ Time Frame: Part 1, 9 months; Part 2, 9 months ] [ Designated as safety issue: No ]
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A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
Not Provided

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).

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: ARRY-614, p38/Tie2 inhibitor; oral
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule
Experimental: ARRY-614
Intervention: Drug: ARRY-614, p38/Tie2 inhibitor; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
Not Provided
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01496495
ARRAY-614-112
Not Provided
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP