Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT02181660 | Completed Phase 1 DMC

• 1 other identifier: 2215-CL-0102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

The objectives of this study are to determine the safety and tolerability of ASP2215 as well as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT) and/or determine the recommended dose (RD) of ASP2215 for the next phase in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML).

Conditions

Acute Myeloid Leukemia (AML)

Keywords

AML; Acute myeloid leukemia; Gilteritinib; ASP2215

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability assessed through adverse events to determine maximum tolerated dose

  Up to 17 months

Secondary Outcomes (25)

• Response Rate

  Up to 16 months

• Pharmacokinetics of ASP2215 in plasma: AUCinf

  Cycle 0 Day -2 through Cycle 1 Day 1

• Pharmacokinetics of ASP2215 in plasma: AUClast

  Cycle 0 Day -2 through Cycle 1 Day 1

• Pharmacokinetics of ASP2215 in plasma: AUC24

  Cycle 0 Day -2 through Cycle 1 Day 1

• Pharmacokinetics of ASP2215 in plasma: AUC48

  Cycle 0 Day -2 through Cycle 1 Day 1

Study Arms (1)

Dose Escalation Cohort

EXPERIMENTAL

ASP2215

Drug: Gilteritinib

Interventions

Gilteritinib DRUG

oral

Also known as: ASP2215

Dose Escalation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is defined as morphologically documented primary or secondary acute myeloid leukemia (AML) according to the World Health Organization (WHO) criteria (2008) and fulfills one of the following:
• Refractory to prior induction chemotherapy
• Relapsed after achieving remission with prior therapy
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
• Subject's interval from prior treatment to the time of study drug administration is at least 14 days for antineoplastic agents other than ASP2215 (except for hydroxyurea, which is given to control blast cells).
• Subject's interval from prior treatment to the time of study drug (ASP2215) administration is at least 5 half-lives (if the half-life is unknown, 14 days) for other investigational products or drugs used for immunosuppressive therapy posthematopoietic stem cell transplantation (HSCT).

You may not qualify if:

• Subject was diagnosed with acute promyelocytic leukemia (APL).
• Subject has breakpoint cluster region-abelson (BCR-ABL)-positive leukemia (chronic myelogenous leukemia in blast crisis)
• Subject has active malignant tumors other than AML or myelodysplastic syndrome (MDS)
• Subject has persistent non-hematological toxicities of ≥ Grade 2 (CTCAE v4), with symptoms and objective findings, due to prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, investigational products, radiation therapy, and surgery)
• Subject has received hematopoietic stem cell transplant (HSCT) and falls under either of the following:
• Is within 2 months of transplant
• Has persistent and clinically significant graft-versus-host disease requiring treatment
• Has persistent non-hematological toxicities of ≥ Grade 2 related to the transplant
• Subject has clinically active central nervous system leukemia
• Subject has disseminated intravascular coagulation (DIC)
• Subject has had major surgery within 28 days prior to the first study drug administration
• Subject has had radiation therapy within 28 days prior to the first study drug administration
• Subject has congestive heart failure of NYHA class 3 or 4, or subject with a past history of congestive heart failure of NYHA class 3 or 4 and in whom echocardiogram or Multiple Gate Acquisition (MUGA) scan performed within 3 months prior to screening or at screening showed a left ventricular ejection fraction (LVEF) of \< 45%.
• Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of CYP3A4 or of P-gp with such exceptions of antibiotics, antifungals, and antivirals that are considered absolutely essential for prevention or treatment of infections and for which the physician judged that there are no interchangeable drugs.
• Subject requires treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptors, with the exception of drugs that are considered absolutely essential for treatment of the subject.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Site JP00002

Aichi, Japan

Location

Site JP00003

Fukuoka, Japan

Location

Site JP00001

Gunma, Japan

Location

Site JP00004

Tokyo, Japan

Location

Site JP00005

Tokyo, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

gilteritinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 4, 2014
• Study Start: June 16, 2014
• Primary Completion: June 27, 2016
• Study Completion: June 27, 2016
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)