A Phase 1 interventional study of vosaroxin and Azacitidine in Myelodysplastic Syndromes, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-02.
Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Treatment
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.
2,165 studies on the registry are indexed under Myelodysplastic Syndromes; 322 are open to participants now.
This study's enrollment of 35 is below the median of 39 across 1,771 interventional studies indexed under Myelodysplastic Syndromes.
Browse Myelodysplastic Syndromes studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Diagnosis of myelodysplastic syndrome and one of the following:
Adequate renal and hepatic function defined as all of the following:
Exclusion Criteria:
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.
Drug: vosaroxin · Drug: Azacitidine
Given IV over 10 minutes on Day 1 and 4
Also known as: voreloxin
Given SC or IV over 15 minutes on days 1-7
Also known as: Vidaza, Ladakamycin
MTD of vosaroxin in combination with azacitidine
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
Time frame: 28 days
Best response (including hematologic improvement)
According to the modified IWG criteria. Summarized as proportion with 95% confidence intervals.
Time frame: At 3 cycles
Best overall response
According to the modified IWG criteria. Summarized as proportion with 95% confidence intervals
Time frame: Up to 7 months
Incidence of adverse events
Graded according to NCI CTCAE v. 4.0. summarized by grade, type and patient.
Time frame: Up to 7 months
Time to response
According to the modified IWG criteria. Described using Kaplan-Meier models to plot these endpoints and estimate median times with a 95% confidence interval.
Time frame: Up to 7 months
Event-free survival
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.
Time frame: up to 5 years
Progression-free survival (PFS)
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.
Time frame: up to 5 years
Disease-free survival (DFS)
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.
Time frame: up to 5 years
Overall survival (OS)
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.
Time frame: up to 5 years
Biomarkers of response to vosaroxin and azacitidine therapy
Serial estimate of biomarker expression will be plotted and summarized over time using means and standard deviations, possibly on a log scale
Time frame: Up to 5 years
Plan to share: No
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vosaroxin · Azacitidine
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