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



Status:Completed
Conditions:Blood Cancer, Lymphoma, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:12/16/2016
Start Date:August 2008
End Date:April 2016

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A Phase I, Dose-Ranging Study to Evaluate the Pharmacokinetics and Safety of Azacitidine Administered Subcutaneously (SC) and as Different Oral Formulations in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), Acute Myelogenous Leukemia (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.


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
We found this trial at
11
sites
1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Albuquerque, New Mexico 87109
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Greenbrae, California 94904
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Houston, Texas 77030
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Ocoee, FL
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San Antonio, TX
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Springfield, Oregon 97477
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St. Louis, Missouri 63108
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2811 Tieton Drive
Yakima, Washington 98902
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