Status:
COMPLETED
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
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 syndromes (MDS) will receive investigational study drug ARRY-614. This study has 2 parts. In the first pa...
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) 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.
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2015
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01496495
Start Date
January 1 2012
End Date
March 18 2015
Last Update
September 9 2020
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030