Status:
COMPLETED
Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
Lead Sponsor:
Celgene
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
Eligibility Criteria
Inclusion
- 18 years or older
- Diagnosis of MDS or CMML
- Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
- ECOG Performance Status 0-2
- Use of acceptable birth control
- Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
- Serum bicarbonate greater than or equal to 20 mEq/L
- Platelet count greater than or equal to 25,000/uL
- Hemoglobin greater than or equal to 500/uL
- Signed informed consent
Exclusion
- Diagnosis of acute promyelocytic leukemia
- Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
- Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
- Hypersensitivity to azacitidine or mannitol
- Active, uncontrolled infection
- Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
- Known or active HIV, viral hepatitis B or C
- Breastfeeding or pregnant females
- Current or uncontrolled cardiac disease
Key Trial Info
Start Date :
August 12 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00761722
Start Date
August 12 2008
End Date
April 7 2016
Last Update
November 8 2019
Active Locations (11)
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1
California Cancer Care Inc
Greenbrae, California, United States, 94904
2
Main Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
3
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160