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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761722
First Posted: September 29, 2008
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene Corporation
  Purpose
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.

Condition Intervention Phase
Acute Myeloid Leukemia Myelodysplastic Syndromes Lymphoma Multiple Myeloma Leukemia, Myelomonocytic, Chronic Drug: azacitidine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • To estimate the dose for a given oral formulation that would yield similar exposure [area under the curve (AUC)] to 75 mg/m2 of the subcutaneous formulation. [ Time Frame: 1 - 18 months ]

Secondary Outcome Measures:
  • To determine the oral bioavailability of up to 6 different oral formulations in comparison to the subcutaneous formulation [ Time Frame: 1 - 18 months ]
  • To assess the safety and tolerability of subcutaneous and oral formulations of azacitidine [ Time Frame: 1 - 18 months ]
  • To assess response rates [ Time Frame: 1 - 18 months ]
  • To assess RBC transfusion independence [ Time Frame: 1 - 18 months ]
  • To investigate the pharmacokinetics of oral azacitidine [ Time Frame: 1 -18 months ]
  • To assess the pharmacodynamic effects of oral azacitidine [ Time Frame: 1 -18 months ]

Enrollment: 31
Study Start Date: August 2008
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.

Drug: 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 Name: Vidaza
Experimental: 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.

Drug: 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 Name: Vidaza

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761722


Locations
United States, California
California Cancer Care Inc
Greenbrae, California, United States, 94904
United States, Florida
Main Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Mexico
Northwest Cancer Specialists, P.C.
Albuquerque, New Mexico, United States, 87109
United States, Oregon
Willamette Valley Cancer Institute
Springfield, Oregon, United States, 97477
United States, Texas
University of Texas- MD Anderson
Houston, Texas, United States, 77030
Hematology and Oncology Assoc. of South Texas
San Antonio, Texas, United States, 78229
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-4417
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Barry Skikne, MD, FACP, FCP (SA) Celgene Corporation
  More Information

Publications:
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00761722     History of Changes
Other Study ID Numbers: AZA PH US 2008 CL008
First Submitted: September 25, 2008
First Posted: September 29, 2008
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by Celgene Corporation:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Lymphoma
Multiple Myeloma
Chronic Myelomonocytic Leukemia (CMML)

Additional relevant MeSH terms:
Lymphoma
Syndrome
Leukemia
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Chronic
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases
Azacitidine
Antimetabolites, Antineoplastic