Phase 3 study of quizartinib
Phase 3
Completed
- Conditions
- ewly diagnosed AM
- Registration Number
- JPRN-jRCT2080223611
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
1.Newly diagnosed, morphologically documented primary AML or AML secondary to myelodysplastic syndrome or a myeloproliferative neoplasm (at Screening)
2.Eastern Cooperative Oncology Group performance status 0-2 (at Screening)
Exclusion Criteria
1.Diagnosis of acute promyelocytic leukemia (APL), chronic myelogenous leukemia in blast crisis
2.Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Overall Survival <br>Overall survival, defined as the time from Randomization until death from any cause
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>Event Free Survival (EFS) <br>EFS is defined as the time from Randomization until the date of the earliest of any of the following: <br>1. Refractory disease (or treatment failure) which is determined at the end of the Induction Phase <br>2. Relapse after CR or CRi <br>3. Death from any cause at any time during the study<br>Complete Remission (CR) Rate at the End of Induction <br>Composite CR Rate at the End of Induction, etc<br>Percentage of Participants Achieving CR With FLT3-ITD Minimal Residual Disease Negativity<br>Percentage of Participants Achieving Composite CR With FLT3-ITD Minimal Residual Disease Negativity, etc