Phase 1b study of quizartinib
Phase 1
Completed
- Conditions
- ewly diagnosed AM
- Registration Number
- JPRN-jRCT2080223254
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
This study demonstrated that doses of quizartinib 20 mg once daily or 40 mg once daily in combination with standard chemotherapy are generally well-tolerated. The Cmax and AUCtau values of quizartinib, AC886, and quizartinib + AC886 increased as dose increased within the dose range tested. The pharmacokinetic profiles of quizartinib and AC886 were similar to those in the previous study which conducted in overseas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
No prior treatment for AML (including quizartinib)
-ECOG Performance Status (PS) of 0 to 2
Exclusion Criteria
-Diagnosis of acute promyelocytic leukemia
-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
- Secondary Outcome Measures
Name Time Method