Status:
COMPLETED
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Lead Sponsor:
Array Biopharma, now a wholly owned subsidiary of Pfizer
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 par...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00916227
Start Date
June 1 2009
Last Update
September 9 2020
Active Locations (3)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030