Status:
COMPLETED
A Study of ARRY-520 in Patients With Advanced Myeloid Leukemia
Lead Sponsor:
Pfizer
Conditions:
Advanced MDS
Acute Myeloid Leukemia
Eligibility:
All Genders
17+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a 2-phase study during which patients with select myeloid leukemias or advanced myelodysplastic syndrome (MDS), who have failed, refused or are not eligible for standard treatment, will receiv...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria (Part 2):
- Patients with either Intermediate-2 or High risk MDS or with AML (\>20% bone marrow blasts) with stable low or normal white blood cell count (WBC). Patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
- Discontinuation of prior treatment at least 2 weeks prior to the start of the study.
- Adequate hepatic and renal function.
- Additional criteria exist.
- Key Exclusion Criteria (Part 2):
- Concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers.
- Previous radiation to \>25% of bone marrow.
- Other active malignancies.
- Known positive serology for the human immunodeficiency virus (HIV).
- Central nervous system involvement as documented by spinal fluid cytology.
- Active, uncontrolled infection.
- Additional criteria exist
Exclusion
Key Trial Info
Start Date :
March 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00637052
Start Date
March 18 2008
End Date
June 21 2010
Last Update
February 8 2021
Active Locations (2)
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1
Emory University School of Medicine, Winship Cancer Center
Atlanta, Georgia, United States, 30322
2
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, United States, 77030