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COMPLETEDPhase 1NCT00761722

Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma

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.

Lead sponsor: Celgene•11 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Celgene

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 8, 2019Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment31

Start dateAug 2008

Last updatedNov 8, 2019

Condition

Acute Myeloid Leukemia Myelodysplastic Syndromes Lymphoma Multiple Myeloma Leukemia, Myelomonocytic, Chronic

Locations shown

California Cancer Care Inc

Greenbrae, California

Main Cancer Centers of Florida, P.A.

Ocoee, Florida

Indiana University School of Medicine

Indianapolis, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 8, 2019Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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