Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza

NCT01290302 | Completed Phase 1 Results

• 1 other identifier: 1AZA10001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelodysplastic Syndrome; Myelofibrosis; Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (3)

• Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t)

  The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUC 0-t is defined as AUC from time 0 to the last data point

  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 Curve From Time Zero Extrapolated to Infinity (AUC 0-∞)

  The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC 0-∞ is defined as area under the concentration vs. time curve from zero to infinity.

  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)

  Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample.

  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

Study Arms (2)

Luitpold Azacitidine first, then Vidaza®

EXPERIMENTAL

Participants first received Luitpold Azacitidine subcutaneously (SC) on Day 1. After a washout period of 24 hours, they then received Vidaza on Day 2.

Drug: Luitpold Azacitidine

Vidaza® first, then Luitpold Azacitidine

ACTIVE COMPARATOR

Participants first received Vidaza subcutaneously (SC) on Day 1. After a washout period of 24 hours, they then received Luitpold Azacitidine on Day 2.

Drug: Vidaza®

Interventions

Luitpold Azacitidine DRUG

Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle

Also known as: Single use vials containing 100 mg azacitidine/vials,.The formulation contained mannitol as an excipient. Lot 090035 and Lot 120011

Luitpold Azacitidine first, then Vidaza®

Vidaza® DRUG

Subcutaneous (SC) at a dose of 75 mg/m\^2 per day on days 1 and 2 of a treatment cycle

Also known as: Vidaza (azacitidine for injection), Celegene Corporation, commercially available formulation. The formulation contained mannitol as a excipient. Lot 91096A

Vidaza® first, then Luitpold Azacitidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (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.

You may not qualify if:

• Hypersensitivity to azacitidine or mannitol.
• Anticipated need for red blood cells (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 hepatitis C virus (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.

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals, Inc.

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes; Primary Myelofibrosis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Azacitidine; Injections

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Marsha Simon
• Organization: Luitpold Pharmaceutical, Inc

msimon@lpicrd.com

631-772-3507

Study Officials

• Joseph Perno, MD,PhD

  Medical Director

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: February 7, 2011
• Study Start: November 22, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 21, 2012
• Last Updated: June 12, 2025
• Results First Posted: May 25, 2025

Record last verified: 2024-11

Locations

US (1)