Status:
WITHDRAWN
A Study of FF-10501-01 in Combination with Azacitidine in Patients with Myelodysplastic Syndrome
Lead Sponsor:
Fujifilm Pharmaceuticals U.S.A., Inc.
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to determine the response rate according to the International Working Group Response criteria for the combination of FF-10501-01 and azacitidine in patients previ...
Detailed Description
This is an open-label, Simon 2-stage clinical study of the combination of FF-10501-01 and azacitidine in previously untreated patients with high-risk MDS, or in patients with myelodysplastic syndrome ...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years of age
- MDS as determined by bone marrow aspirate and/or biopsy according to the WHO Classification within 6 weeks of the first dose of study medication, with bone marrow blast counts of \< 20%.
- Int2/High-risk MDS according to the IPSS, Intermediate/high/very high-risk MDS according to the IPSS-R, or otherwise eligible for treatment with azacitidine in the judgment of the Investigator
- ECOG Performance Score of 0 or 1
- Adequate hepatic function as evidenced by AST/ALT \< 3X the ULN and total bilirubin \< 2X the ULN for the reference lab
- Adequate renal function as evidenced by serum creatinine \< 2 mg/dL or a calculated creatinine clearance of \> 50 mL/min
Exclusion
- A current infection requiring treatment with intravenous antibiotics, anti-fungal agents, or anti-viral agents
- Previous treatment with a hypomethylating agent, an HDAC inhibitor, or any other drug intended for the treatment of MDS other than hematopoietic growth factors, immunosuppressive therapy or hydroxyurea. Patients with 5q deletions may have received prior lenalidomide.
- Use of hematopoietic growth factors (erythropoietin, G-CSF, GM-CSF, thrombopoietin receptor agonists) or immunosuppressive treatments within 7 days of first dose of study medication
- Administration of any investigational agent within 5 half-lives of the agent; if the half-life is not known, use of such an agent within 2 weeks of the first dose of study medication
- Active infection with HIV or hepatitis B or C; patients with a history of such disorders should undergo serological testing to evaluate the activity of the infection
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03486353
Start Date
October 1 2019
End Date
October 1 2019
Last Update
December 5 2024
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