Phase 2
N=37
Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Leukemia, Myeloid, Acute
Bottom Line
View on ClinicalTrials.gov: NCT02984995 ↗Enrolled (actual)
37
Serious AEs
46.0%
Results posted
Feb 2020
Primary outcome: Primary: Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML — 56.5; 33.3; 53.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Quizartinib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
56.5; 33.3; 53.8 | — |
| SECONDARY Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
79.2; 66.7; 77.8 | — |
| SECONDARY Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
16.1; NA; 16.1 | — |
| SECONDARY Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
34.1; NA; 34.1 | — |
| SECONDARY Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
12.7; 0.1; 12.7 | — |
| SECONDARY Leukemia-free Survival (LFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
16.1; NA; 16.1 | — |
| SECONDARY Hematopoietic Stem Cell Transplantation Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
37.9; 33.3; 37.5 | — |
| SECONDARY Change in the Area Under the Plasma Concentration Time Curve (AUC) of Quizartinib and Its Active Metabolite After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
877; 1170; 75.1; 560; 2610; 3970 | — |
| SECONDARY Change in the Maximum Plasma Concentration (Cmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
48.1; 76.9; 3.92; 29.1; 127; 211 | — |
| SECONDARY Change in the Trough Plasma Concentration (Ctrough) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
98.2; 128; 17.8; 112 | — |
| SECONDARY Change in the Time to Reach Maximum Plasma Concentration (Tmax) of Quizartinib and Its Metabolite (AC886) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML |
4.08; 4.03; 24.33; 24.32; 4.08; 3.06 | — |
Summary
This is a Phase 2, multi-center, open-label study to evaluate the efficacy, safety and pharmacokinetics of quizartinib monotherapy in Japanese subjects with FLT3-ITD positive refractory or relapsed acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria
- AML patients in first relapse or refractory after all prior therapy
- Presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2
Exclusion Criteria
- Diagnosis of acute promyelocytic leukemia
- AML secondary to prior chemotherapy for other neoplasms.
- Persistent, clinically significant > Grade 1 non-hematologic toxicity from prior AML therapy
- Prior treatment with a FLT3 targeted therapy
- Active infection not well controlled by antibacterial, antifungal and/or antiviral therapy
Data sourced from ClinicalTrials.gov (NCT02984995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.