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

November 6, 2019 updated by: Celgene

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Greenbrae, California, United States, 94904
        • California Cancer Care Inc
    • Florida
      • Ocoee, Florida, United States, 34761
        • Main Cancer Centers of Florida, P.A.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Northwest Cancer Specialists, P.C.
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Institute
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas- MD Anderson
      • San Antonio, Texas, United States, 78229
        • Hematology and Oncology Assoc. of South Texas
    • Washington
      • Seattle, Washington, United States, 98109-4417
        • Fred Hutchinson Cancer Research Center
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/ North Star Lodge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Vidaza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 - 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Barry Skikne, MD, FACP, FCP (SA), Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 12, 2008

Primary Completion (ACTUAL)

April 6, 2016

Study Completion (ACTUAL)

April 7, 2016

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (ESTIMATE)

September 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZA PH US 2008 CL008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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