Safety, Pharmacokinetics, and Pharmacodynamics of Oral Azacitidine in Subjects With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myelogenous Leukemia
NCT ID: NCT00528983
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
133 participants
INTERVENTIONAL
2007-09-11
2016-04-05
Brief Summary
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Detailed Description
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Subjects who are entering the OEP should be discontinued from Part 1 or Part 2 protocol prescribed therapy in the AZA PH US 2007 CL 005 study.
Subjects may continue to receive oral azacitidine in the OEP until they meet the criteria for study discontinuation or oral azacitidine becomes commercially available. Subjects discontinuing from the OEP will have an OEP discontinuation visit 28 days after the last dose of study drug or at study withdrawal.
Primary Objective of OEP is to evaluate long term safety of oral azacitidine.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Subcutaneous (SC) Azacitidine and Oral Azacitidine
Cycle 1 subjects receive SC Azacitidine for first 7 days of 28 day cycle. For Cycle 2 and beyond subjects receive Oral Azacitidine (experimental) for first 7 days of 28 day cycle.
Subcutaneous (SC) Azacitidine
75 mg/day for first 7 days of 28 day cycle for 1 cycle only.
Oral Azacitidine
Cycle 2 and beyond starting dose of 120 mg/day for first 7 days of 28 day cycle. Dose will escalate in increments of 60 mg. Following evaluation dose escalation will occur in 120 mg increments until maximum tolerated dose (MTD) is reached.
Oral Azacitidine
Subjects receive Oral Azacitidine (experimental) QD or BID for the first 14 or 21 days of 28 day cycle.
Oral Azacitidine
Starting dose for 14 day-QD treatment schedule will be 300 mg/day. Starting dose for 14 day-BID, 21 day-QD, 21 day-BID treatment schedules will be 100 mg, 200mg, 300mg. Dose will escalate in increments of 100 mg until MTD is reached.
Interventions
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Subcutaneous (SC) Azacitidine
75 mg/day for first 7 days of 28 day cycle for 1 cycle only.
Oral Azacitidine
Cycle 2 and beyond starting dose of 120 mg/day for first 7 days of 28 day cycle. Dose will escalate in increments of 60 mg. Following evaluation dose escalation will occur in 120 mg increments until maximum tolerated dose (MTD) is reached.
Oral Azacitidine
Starting dose for 14 day-QD treatment schedule will be 300 mg/day. Starting dose for 14 day-BID, 21 day-QD, 21 day-BID treatment schedules will be 100 mg, 200mg, 300mg. Dose will escalate in increments of 100 mg until MTD is reached.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of low or Int-1 risk MDS
* Low platelet count, and/or low hemoglobin, and/or RBC transfusion-dependent and/or platelet transfusion-dependent
* ECOG Performance status 0-2
* Standard safety inclusion for serum creatinine, AST, ALT, bilirubin.
* Serum bicarbonate greater than or equal to 20 mEq/L.
* Use of acceptable birth control.
* Signed, written informed consent.
Exclusion Criteria
* Previous or concurrent malignancy.
* Prior treatment with azacitidine or other demethylating agents.
* Treatment with any anticancer therapy or investigational drugs within 21 days.
* Hypersensitivity to azacitidine or mannitol.
* Presence of GI disease.
* Active, uncontrolled infection.
* Known Human Immunodeficiency Virus (HIV) or Hepatitis C, or known active viral Hepatitis B.
* Breastfeeding or Pregnant females;
* Presence of serious illness, medical condition, or other medical history which would be likely to interfere with a subject's participation in the study or with the interpretation of the results.
* Current congestive heart failure (NY Heart Association Class III-IV), unstable angina or angina requiring surgical or medical intervention within 6 months, myocardial infarct within 6 months, or uncontrolled cardiac arrhythmia.
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, M.D., FACP; FCP (SA)
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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University of Florida
Gainesville, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Kansas University Medical Center
Westwood, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New York Oncology Hematology P.C.
Albany, New York, United States
Institute for Translational Oncology Research IRB
Greenville, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology Cancer Care
Austin, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
HOAST
San Antonio, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, 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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Garcia-Manero G, Gore SD, Cogle C, Ward R, Shi T, Macbeth KJ, Laille E, Giordano H, Sakoian S, Jabbour E, Kantarjian H, Skikne B. Phase I study of oral azacitidine in myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia. J Clin Oncol. 2011 Jun 20;29(18):2521-7. doi: 10.1200/JCO.2010.34.4226. Epub 2011 May 16.
Garcia-Manero G, Gore SD, Kambhampati S, Scott B, Tefferi A, Cogle CR, Edenfield WJ, Hetzer J, Kumar K, Laille E, Shi T, MacBeth KJ, Skikne B. Efficacy and safety of extended dosing schedules of CC-486 (oral azacitidine) in patients with lower-risk myelodysplastic syndromes. Leukemia. 2016 Apr;30(4):889-96. doi: 10.1038/leu.2015.265. Epub 2015 Oct 7.
Laille E, Shi T, Garcia-Manero G, Cogle CR, Gore SD, Hetzer J, Kumar K, Skikne B, MacBeth KJ. Pharmacokinetics and Pharmacodynamics with Extended Dosing of CC-486 in Patients with Hematologic Malignancies. PLoS One. 2015 Aug 21;10(8):e0135520. doi: 10.1371/journal.pone.0135520. eCollection 2015.
Other Identifiers
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AZA PH US 2007 CL005
Identifier Type: -
Identifier Source: org_study_id
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