- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01290302
Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
January 22, 2018 updated by: American Regent, Inc.
Blinded Cross-over Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
The purpose of this study is to assess the bioequivalence of subcutaneous Vidaza® and subcutaneous Luitpold Azacitidine pharmacokinetics and to assess the comparative safety of subcutaneous Vidaza® versus subcutaneous Luitpold Azacitidine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To assess the bioequivalence of Vidaza® and Luitpold Azacitidine pharmacokinetics, in terms of Cmax, AUC0-t and AUC0-∞, following SC administration.
To assess the comparative safety of Vidaza® versus Luitpold Azacitidine during the 2 day study period.
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
Pennsylvania
-
Norristown, Pennsylvania, United States, 19403
- Luitpold Pharmaceuticals, Inc.
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-
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:
- Signed informed consent obtained prior to initiation of any study-specific procedures.
- Patients with one of the following - myelodysplastic syndrome of the following French-American- British (FAB) subtypes: refractory anemia (RA), RA with ringed sideroblasts (if accompanied by neutropenia, or thrombocytopenia, or requiring transfusion), RA with excess of blasts (RAEB), RAEB in transformation (RAEB-T), or chronic myelomonocytic leukemia (CMMoL); myelofibrosis; chronic myeloid leukemia; or chronic lymphocytic leukemia who's physician feels should receive azacitidine.
- Male or female patients aged at least 18 years.
- ECOG Performance Status 0-2.
- Life expectancy > or = to 3 months.
- Adequate organ function, including the following: Hepatic - Total bilirubin < or = to 1.5 x the upper limit of normal (ULN), aspartate transaminases (AST) and alanine transaminases (ALT) < or = to 2 x ULN and Renal - Serum creatinine < or = to 1.5 x ULN.
- Female patients of child-bearing potential must have a negative pregnancy test and must be using at least one form of contraception as approved by the Investigator for 4 weeks prior to the study and 4 months after the last dose of azacitidine.
- Male patients must use a form of barrier contraception approved by the investigator during the study and for 4 months after the last dose of azacitidine.
Exclusion Criteria:
- Hypersensitivity to azacitidine or mannitol.
- Anticipated need for RBC or platelet transfusion 2 days prior to or up to 2 days after treatment initiation.
- Chemotherapy (excluding previous azacitidine treatment) or radiotherapy within 4 weeks of randomization (6 weeks for nitrosoureas or mitomycin C).
- Significant electrophysical abnormalities in pre-trial EKG.
- Present history of locally advanced or metastatic malignant disease or leukemia.
- Use of recreational drugs or history of drug addiction, within the prior 6 months.
- Known history of a positive hepatitis screen, including hepatitis B surface antigens or HCV antibodies.
- Known history of HIV or syphilis.
- History of clinically significant adverse events due to chemotherapy, radiotherapy or investigational agents.
- Presence of an advanced malignant hepatic tumor.
- Presence of an ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders.
- Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patients compliance.
- Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to study entry.
- Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
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: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Luitpold Azacitidine
|
Subcutaneous (SC) at a dose of 75 mg/m2 per day on days 1 and 2 of a treatment cycle
|
ACTIVE_COMPARATOR: Vidaza®
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Subcutaneous (SC) at a dose of 75 mg/m2 per day on days 1 and 2 of a treatment cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the Concentration Time Curve (AUC0-t)
Time Frame: Blood will be drawn pre-dose, and 0.125, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after dosing on days 1 and 2
|
Pharmacokinetic Analysis
|
Blood will be drawn pre-dose, and 0.125, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after dosing on days 1 and 2
|
Area under the Concentration Time Curve Extrapolated to Infinity (AUC0-∞)
Time Frame: Blood will be drawn pre-dose, and 0.125, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after dosing on days 1 and 2
|
Pharmacokinetic Analysis
|
Blood will be drawn pre-dose, and 0.125, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after dosing on days 1 and 2
|
Observed maximal concentration (Cmax)
Time Frame: Blood will be drawn pre-dose, and 0.125, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after dosing on days 1 and 2
|
Blood will be drawn pre-dose, and 0.125, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, and 10 hours after dosing on days 1 and 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
January 10, 2011
First Submitted That Met QC Criteria
February 3, 2011
First Posted (ESTIMATE)
February 7, 2011
Study Record Updates
Last Update Posted (ACTUAL)
January 24, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Precancerous Conditions
- Leukemia, B-Cell
- Syndrome
- Myelodysplastic Syndromes
- Primary Myelofibrosis
- Leukemia
- Leukemia, Myeloid
- Preleukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Azacitidine
Other Study ID Numbers
- 1AZA10001
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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