Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Conditions
Acute Myeloid Leukemia
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Acute Myeloid Leukemia, ASP2215
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ASP2215
Type: Drug
Overall Status
Recruiting
Summary
The objective of this study is to assess the safety and tolerability, including the maximum tolerated dose, of ASP2215 in subjects with relapsed or treatment-refractory acute myeloid leukemia (AML). This study will also determine the pharmacokinetic (PK) parameters of ASP2215.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Subject is defined as morphologically documented primary or secondary AML by the World Health Organization (WHO) criteria (2008) and fulfills one of the following:

- Refractory to at least 1 cycle of induction chemotherapy

- Relapsed after achieving remission with a prior therapy

- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

- Subject's interval from prior treatment to time of study drug administration is at least 2 weeks for cytotoxic agents (except hydroxyurea given for controlling blast cells), or at least 5 half-lives for prior experimental agents or noncytotoxic agents.

Exclusion Criteria:

- Subject was diagnosed as acute promyelocytic leukemia (APL).

- Subject has 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 nonhematological toxicities of >= Grade 2 (Common Terminology Criteria for Adverse Events v4), with symptoms and objective findings, from prior AML treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, or surgery).

- Subject has had hematopoietic stem cell transplant (HSCT) and meets any of the following:

- Is within 2 months of transplant from C1D1

- Has clinically significant graft-versus-host disease requiring treatment

- Has >= Grade 2 persistent non-hematological toxicity related to the transplant. Donor lymphocytes infusion (DLI) is not permitted <= 30 days prior to study registration or during the first cycle of treatment on the study in Cohort 1 and first two cycles of the treatment in Cohort 2

- Subject has clinically active central nervous system leukemia

- Subject has disseminated intravascular coagulation abnormality (DIC)

- Subject has had major surgery within 4 weeks prior to the first study dose.

- Subject has had radiation therapy within 4 weeks prior to the first study dose

- Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45%

- Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of Cytochrome P450-isozyme3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject

- Subject required treatment with concomitant drugs that target serotonin 5HT1R or 5HT2BR receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.

- Subject has an active uncontrolled infection

- Subject is known to have human immunodeficiency virus infection

- Subject has active hepatitis B or C, or other active hepatic disorder
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Recruiting
Mayo Clinic
Scottsdale, Arizona, United States
Status: Recruiting
City of Hope National Medical Center
Duarte, California, United States
Status: Recruiting
UCLA Medical Center
Los Angeles, California, United States
Status: Recruiting
University of California - San Francisco
San Francisco, California, United States
Status: Recruiting
Stanford Comprehensive Center
Stanford, California, United States
Status: Withdrawn
Mayo Clinic Florida, Clinical Trials Referral Office
Jacksonville, Florida, United States
Status: Recruiting
Northwestern University Medical Center
Chicago, Illinois, United States
Status: Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Status: Recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Status: Recruiting
University of Maryland Medical Center
Baltimore, Maryland, United States
Status: Recruiting
University of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Mayo Clinic
Rochester, Minnesota, United States
Status: Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, United States
Status: Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Status: Recruiting
Columbia University Medical Center
New York, New York, United States
Status: Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Weill Cornell Medical College
New York, New York, United States
Status: Recruiting
The Cleveland Clinic
Cleveland, Ohio, United States
Status: Recruiting
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Status: Recruiting
University of Pennsylvania-Abramson CCC-Dept.of Hem Onc
Philadelphia, Pennsylvania, United States
Status: Recruiting
Medical Center for the University of South Carolina
Charleston, South Carolina, United States
Status: Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Status: Recruiting
MD Anderson Cancer Ctr
Houston, Texas, United States
Status: Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, United States
Status: Recruiting
CHU d'Angers
Angers, France
Status: Recruiting
CHU de Grenoble - Hopital Albert Michallon
Grenoble Cedex, France
Status: Recruiting
Hopital Haut Leveque
Pessac, France
Status: Recruiting
Charite Universitaetsmedizin Berlin
Berlin, Germany
Status: Recruiting
University Hospital Carl Gustav Carus at the Technical University of Dresden
Dresden, Germany
Status: Recruiting
Universitaetsklinikum Magdeburg
Magdeburg, Germany
Status: Recruiting
Universitätsklinikum Giessen und Marburg GmbH
Marburg, Germany
Status: Recruiting
Universitaetsklinikum Ulm
Ulm, Germany
Status: Withdrawn
Azienda Ospedaliero- Universitaria Policlinico S. Orsola Malpighi
Bologna, Italy
Status: Recruiting
Start Date
October 2013
Completion Date
June 2018
Sponsors
Astellas Pharma Global Development, Inc.
Source
Astellas Pharma Inc
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page