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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04493138
Other study ID # 2019-1178
Secondary ID NCI-2020-0526120
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 21, 2020
Est. completion date December 31, 2025

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Guillermo M. Bravo
Phone 713-794-3604
Email ggarciam@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I/II trial studies the side effects and best dose of quizartinib when given with azacitidine and to see how well they work in treating patients with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations. Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine and quizartinib may help to control myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm.


Description:

PRIMARY OBJECTIVES: I. To determine the safety, tolerability and maximum tolerable dose (MTD) of quizartinib in combination with azacytidine. II. To assess overall response (ORR) rate to quizartinib in combination with azacitidine. SECONDARY OBJECTIVES: I. To assess overall survival (OS), duration of response, leukemia-free survival (LFS), relapse-free survival (RFS) and safety profile. II. Correlative studies. OUTLINE: This is a phase I, dose-escalation study of quizartinib followed by a phase II study. Patients receive azacitidine subcutaneously (SC) or intravenously (IV) over about 30 minutes on days 1-5 and quizartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.


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Study Design


Related Conditions & MeSH terms

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Intervention

Drug:
Azacitidine
Given SC or IV
Quizartinib
Given PO

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall response rate Will be defined as complete remission, partial remission, complete remission with incomplete count recovery, marrow compete remission or hematological improvement. Will be estimated for all patients along with the 95% credible interval. At least 4 cycles of therapy in the absence of progression (1 cycle = 28 days)
Primary Overall survival Will be listed and summarized by the Kaplan-Meier estimator. Time from treatment start till death or last follow-up, assessed up to 2 years
Primary Duration of response Will be listed and summarized by the Kaplan-Meier estimator. Duration from the first documented onset of partial response or complete response to the date of progressive disease/relapse, assessed up to 2 years
Primary Relapse-free survival Will be listed and summarized by the Kaplan-Meier estimator. Time from start of response to the date of event defined as the first documented progressive disease/relapse or death, whichever comes first, assessed up to 2 years
Primary Leukemia free survival Will be listed and summarized by the Kaplan-Meier estimator. Time from treatment start to the time of progression to leukemia or death, assessed up to 2 years
Primary Incidence of adverse events (AEs) The severity of the toxicities will be graded according to the latest version of National Cancer Institute Common Terminology Criteria for Adverse Events. The number and percent of subjects with treatment-emergent adverse events will be summarized according to intensity and drug relationship, and categorized by System Organ Class and preferred term by dose level/Part. All reported AEs that occur after signing informed consent will be included in the analysis of all reported AEs. Exposure to study drug and reasons for discontinuation of study drug will be tabulated. Up to 2 years
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