Myelodysplastic SyndromePhase 1NCT01290302
Blinded Cross-Over Bioequivalence (BE) Trial of Luitpold Azacitidine vs Vidaza
A Phase 1 study testing Luitpold Azacitidine and Vidaza® in people with Myelodysplastic Syndrome and Myelofibrosis, run by American Regent, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia
- What is being tested?
- Luitpold Azacitidine and Vidaza®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2010to 21 Dec 2012
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, 19403
About this study
Official title: 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.
Read the detailed description
To assess the bioequivalence of Vidaza® and Luitpold Azacitidine pharmacokinetics, in terms of Maximal Concentration (Cmax), Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC 0-t), and Area Under the Curve From Time Zero Extrapolated to Infinity (AUC 0-∞), following SC administration.
To assess the comparative safety of Vidaza® versus Luitpold Azacitidine during the 2 day study period.
- Conditions
- Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia
- Being tested
- Luitpold Azacitidine, Vidaza®
- Medical subject headings
- Myelodysplastic Syndromes, Primary Myelofibrosis, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luitpold AzacitidineDrug
Also called Single use vials containing 100 mg azacitidine/vials,.The formulation contained mannitol as an excipient. Lot 090035 and Lot 120011
Subcutaneous (SC) at a dose of 75 mg/m^2 per day on days 1 and 2 of a treatment cycle
Vidaza®Drug
Also called Vidaza (azacitidine for injection), Celegene Corporation, commercially available formulation. The formulation contained mannitol as a excipient. Lot 91096A
Subcutaneous (SC) at a dose of 75 mg/m^2 per day on days 1 and 2 of a treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vidaza® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study start22 Nov 2010
- Primary completionDec 2012
- Study completion21 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Regent, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Perno, MD,PhD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290302
- Sponsor's protocol ID
- 1AZA10001
- Status last verified
- Nov 2024
- First submitted
- 10 Jan 2011
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No