Clinical trial NCT02984995: Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation
Official title: Phase 2 Open-label, Single-arm Study of Quizartinib (AC220) Monotherapy in Japanese Patients With FLT3-ITD Positive Refractory or Relapsed Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia, Myeloid, Acute
Keywords: FLT3-ITD
Positive refractory or relapsed acute myeloid leukemia
Hematology malignancy
Developmental Phase II
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2016-12-07
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Composite Complete Remission (CRc) Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation
Secondary outcomes:
measure: Best Response After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML
measure: Response Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML
measure: Duration of Composite Complete Remission (CRc) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 up until the end of treatment, except for responses from any subsequent AML therapy including transplantation
measure: Overall Survival (OS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 1 year
measure: Event-free Survival (EFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 32 weeks
measure: Leukemia-free Survival (LFS) After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Baseline, cycle 2 day 1, cycle 3 day 1, cycle 4 day 1 until the end of treatment, except for responses from any subsequent AML therapy including transplantation up to 28 weeks
measure: Hematopoietic Stem Cell Transplantation Rate After Treatment With Quizartinib in Japanese Participants With FLT3-ITD Positive Relapsed or Refractory AML
timeFrame: Up to new AML treatment or 1 year post treatment
measure: 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
timeFrame: Cycle 1, Days 1 and 15; Cycle 2, Day 1
measure: 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
timeFrame: Cycle 1, Days 1 and 15; Cycle 2, Day 1
measure: 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
timeFrame: Cycle 1, Day 15
measure: 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
timeFrame: Cycle 1, Days 1 and 15; Cycle 2, Day 1
Other outcomes:
Locations:
city: Aichi
country: Japan
city: Akita
country: Japan
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Gifu
country: Japan
city: Gunma
country: Japan
city: Hiroshima
country: Japan
city: Hokkaido
country: Japan
city: Ibaraki
country: Japan
city: Kagoshima
country: Japan
city: Kanagawa
country: Japan
city: Kyoto
country: Japan
city: Miyagi
country: Japan
city: Nagasaki
country: Japan
city: Nara
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Shizuoka
country: Japan
city: Tochigi
country: Japan
city: Tokyo
country: Japan
city: Toyama
country: Japan
city: Yamagata
country: Japan
city: Yamanashi
country: Japan
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: