- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01913951
Vosaroxin and Azacitidine in Treating Patients With Myelodysplastic Syndromes
April 1, 2024 updated by: Washington University School of Medicine
A Phase I Study of Vosaroxin Plus Azacitidine for Patients With Myelodysplastic Syndrome
This phase I trial studies the side effects and the best dose of vosaroxin when given together with azacitidine in treating patients with myelodysplastic syndromes.
Drugs used in chemotherapy, such as vosaroxin and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
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
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
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
Description
Inclusion Criteria:
Diagnosis of myelodysplastic syndrome and one of the following:
- Cytopenias requiring red blood cell and/or platelet transfusions or neutropenia (ANC <1 X109/L)
- IPSS score of INT-1 or higher at screening
- MDS with excess blasts in transformation as defined by FAB criteria (20-29% bone marrow blasts) or
- Chronic myelomonocytic leukemia
- Age ≥18 years old
Adequate renal and hepatic function defined as all of the following:
- total bilirubin ≤ 2.0 mg/dl, except in cases of Gilbert's disease;
- AST and ALT ≤2.5 institutional ULN;
- serum creatinine within normal institutional limits or estimated creatinine clearance ≥60 mL/min/1.73 m2 by the Cockcroft-Gault equation
- ECOG performance status ≤2
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Females must be surgically or biologically sterile or postmenopausal or if of childbearing potential, must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patients may have received up to 3 prior cycles of hypomethylator therapy (i.e. decitabine or azacitidine) prior to enrollment and may have received supportive care measures (growth factors, erythropoietin stimulating agents, transfusion, etc.
- Either enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases"), which facilitates collection of blood, bone marrow, and skin for correlative studies, or consents to collection of blood, bone marrow, and skin as part of this protocol.
Exclusion Criteria:
- Prior treatment with four or more cycles of hypomethylator therapy.
- Receiving concomitant chemotherapy, radiation therapy, or immunotherapy during the duration of treatment on protocol.
- Known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Patients who are seropositive for HCV, but have a negative viral load are also eligible. Documentation that the patients have completed a course of therapy for HCV is required and will be obtained.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant and/or breastfeeding.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (vosaroxin, azacitidine)
Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and azacitidine SC or IV over 15 minutes on days 1-7.
Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
|
Given IV over 10 minutes on Day 1 and 4
Other Names:
Given SC or IV over 15 minutes on days 1-7
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD of vosaroxin in combination with azacitidine
Time Frame: 28 days
|
Defined as the highest dose of vosaroxin that results in a DLT in =< 1 of 6 patients graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best response (including hematologic improvement)
Time Frame: At 3 cycles
|
According to the modified IWG criteria.
Summarized as proportion with 95% confidence intervals.
|
At 3 cycles
|
Best overall response
Time Frame: Up to 7 months
|
According to the modified IWG criteria.
Summarized as proportion with 95% confidence intervals
|
Up to 7 months
|
Incidence of adverse events
Time Frame: Up to 7 months
|
Graded according to NCI CTCAE v. 4.0.
summarized by grade, type and patient.
|
Up to 7 months
|
Time to response
Time Frame: Up to 7 months
|
According to the modified IWG criteria.
Described using Kaplan-Meier models to plot these endpoints and estimate median times with a 95% confidence interval.
|
Up to 7 months
|
Event-free survival
Time Frame: up to 5 years
|
From the date of first dose of study drug to date of treatment failure, recurrence, or death due to any cause.
Described using Kaplan-Meier models to plot these endpoints and estimate median times with a 95% confidence interval.
|
up to 5 years
|
Progression-free survival (PFS)
Time Frame: up to 5 years
|
From the date of first dose of study drug to disease progression or death from MDS. Described using Kaplan-Meier models to plot these endpoints and estimate median times with a 95% confidence interval.
|
up to 5 years
|
Disease-free survival (DFS)
Time Frame: up to 5 years
|
From the date of first documentation of a complete remission (CR) to date of relapse.
Described using Kaplan-Meier models to plot these endpoints and estimate median times with a 95% confidence interval.
|
up to 5 years
|
Overall survival (OS)
Time Frame: up to 5 years
|
Date of first dose of study drug to the date of death from any cause.
Described using Kaplan-Meier models to plot these endpoints and estimate median times with a 95% confidence interval.
|
up to 5 years
|
Biomarkers of response to vosaroxin and azacitidine therapy
Time Frame: Up to 5 years
|
Serial estimate of biomarker expression will be plotted and summarized over time using means and standard deviations, possibly on a log scale
|
Up to 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Meagan Jacoby, M.D., Ph.D., Washington University School of Medicine
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.
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)
November 22, 2013
Primary Completion (Actual)
December 5, 2016
Study Completion (Estimated)
April 29, 2024
Study Registration Dates
First Submitted
July 30, 2013
First Submitted That Met QC Criteria
July 30, 2013
First Posted (Estimated)
August 1, 2013
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201309091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Myelodysplastic Syndromes
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedPreviously Treated Myelodysplastic Syndromes | Secondary Myelodysplastic Syndromes | de Novo Myelodysplastic SyndromesUnited States
-
National Cancer Institute (NCI)CompletedPreviously Treated Myelodysplastic Syndromes | Secondary Myelodysplastic Syndromes | de Novo Myelodysplastic SyndromesUnited States
-
GCP-Service International West GmbHSaint-Louis Hospital, Paris, France; University of Florence; Medical University... and other collaboratorsNot yet recruitingLow Risk Myelodysplastic SyndromesSpain, Poland, Italy, Germany, France
-
Dana-Farber Cancer InstituteCompletedMyelodysplastic Syndromes (MDS)United States
-
TJ Biopharma Co., Ltd.Recruiting
-
National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RecruitingMyelodysplastic Syndromes (MDS)United States, Israel
-
AbbVieCelgene; Genentech, Inc.CompletedMyelodysplastic Syndromes (MDS)United States, Australia, Germany
-
AbbVieGenentech, Inc.Active, not recruitingMyelodysplastic Syndromes (MDS)United States, Australia, Canada, France, Germany, Italy, United Kingdom
-
The First Affiliated Hospital with Nanjing Medical...UnknownMyelodysplastic Syndromes (MDS)China
-
Sumitomo Pharma America, Inc.TerminatedMyelodysplastic Syndromes (MDS)United States
Clinical Trials on vosaroxin
-
Weill Medical College of Cornell UniversitySunesis PharmaceuticalsCompletedVosaroxin for Intermediate 2 or High-risk MDS After Failure With Hypomethylating Agent-based TherapyMyelodysplastic SyndromeUnited States
-
Sunesis PharmaceuticalsCompletedSmall Cell Lung Cancer | Carcinoma, Small CellUnited States, Canada
-
Sunesis PharmaceuticalsCompletedAcute Myeloid Leukemia | Myelodysplastic Syndromes | Leukemia | Acute Disease | Nonlymphocytic LeukemiaUnited States
-
Sunesis PharmaceuticalsCompletedEpithelial Ovarian CancerUnited States, Canada
-
Sunesis PharmaceuticalsCompletedMyelodysplastic Syndromes | Leukemia, Lymphocytic, Acute | Leukemia, Myeloid, Chronic | Leukemia, Nonlymphocytic, AcuteUnited States
-
Sunesis PharmaceuticalsCompletedCarcinoma, Non-Small-Cell LungUnited States
-
M.D. Anderson Cancer CenterSunesis PharmaceuticalsCompleted
-
University of UlmSunesis PharmaceuticalsCompletedAcute Myeloid Leukemia | Myelodysplastic Syndrome With Excess Blasts-2 (MDS-EB-2)Germany
-
Hamid SayarTerminatedLeukemia, Myeloid, AcuteUnited States
-
Cardiff UniversityCancer Research UKUnknownMyelodysplastic Syndrome | Acute Myeloid LeukaemiaDenmark, United Kingdom