Acute myeloid leukemia
Conditions
Interventions
investigational material(s)
Generic name etc : SGI-110
INN of investigational material : Guadecitabine
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigati
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients with a diagnosis of AML (WHO classification 2008). - Patients, 20 years of age or older, who are unresponsive to standard chemotherapy or have relapsed following standard chemotherapy - Patients, 65 years of age or older, who are not eligible for standard intensive chemotherapy 2) Patients with ECOG performance status (PS) of 0 to 2. 3) Patients with adequate organ function. 4) Women of child-bearing potential must not be pregnant or breast feeding (pregnancy test will be performed at Screening). Women of child bearing potential and all men with female partners of child bearing potential must practice two medically acceptable methods of birth control and must not become pregnant or father a child while receiving treatment with SGI-110 and for 3 months following last dosing. 5) Patients who have undergone prior allogeneic hematopoietic stem cell transplantation must have no evidence of active graft-versus host disease (GVHD) and must be off immunosuppressive therapy by 2weeks or longer prior to IMP administration.
Exclusion criteria
Exclusion criteria: 1) Patients with acute promyelocytic leukemia accompanied by t(15;17)(q22;q12) or (PML/RARA) karyotype abnormalities (include other variant types of APL). 2) Patients with multiple cancers (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 3 years). 3) Subjects with life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at risk. 4) Patients with poorly controlled arrhythmias, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification. 5) Patients with symptomatic central nervous system involvement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Dose Limiting Toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics Pharmacokinetics, Safety | — |
Countries
Japan
Outcome results
None listed