Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
NCT ID: NCT00761722
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2008-08-12
2016-04-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
subcutaneous and oral azacitidine
Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.
azacitidine
Arm 1:
Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.
Arm 2:
All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.
Arm 2
Oral Azacitidine
All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.
azacitidine
Arm 1:
Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.
Arm 2:
All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.
Interventions
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azacitidine
Arm 1:
Cycle 1 (PK Phase) - Subjects will receive a single SC dose of 75 mg/m2 on Days 1 and 15. Single oral doses of a given formulation of azacitidine will be administered in increasing doses on Days 3 and 5, and at doses calculated to deliver 80% and 120% of the SC exposure, up to a maximum dose of 600 mg on Days 17 and 19.
Cycles 2 and beyond - (Treatment phase) Oral azacitidine will be administered in a dose calculated to deliver 100% of the SC exposure up to a maximum of 600 mg on days 1 - 7 of a 28 day cycle.
Arm 2:
All Cycles - Oral azacitidine will be administered a maximum of 600 mg on Days 1 - 7 of a 28 days cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Barry Skikne, MD, FACP, FCP (SA)
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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California Cancer Care Inc
Greenbrae, California, United States
Main Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Washington University School of Medicine
St Louis, Missouri, United States
Northwest Cancer Specialists, P.C.
Albuquerque, New Mexico, United States
Willamette Valley Cancer Institute
Springfield, Oregon, United States
University of Texas- MD Anderson
Houston, Texas, United States
Hematology and Oncology Assoc. of South Texas
San Antonio, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, United States
Countries
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References
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Laille E, Savona MR, Scott BL, Boyd TE, Dong Q, Skikne B. Pharmacokinetics of different formulations of oral azacitidine (CC-486) and the effect of food and modified gastric pH on pharmacokinetics in subjects with hematologic malignancies. J Clin Pharmacol. 2014 Jun;54(6):630-9. doi: 10.1002/jcph.251. Epub 2014 Jan 18.
Other Identifiers
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AZA PH US 2008 CL008
Identifier Type: -
Identifier Source: org_study_id
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