relapsed or refractory peripheral T-cell lymphoma(r/r PTCL), relapsed or refractory cutaneous T-cell lymphoma(r/r CTCL), relapsed or refractory adult T-cell leukemia/lymphoma(r/r ATLL)
Conditions
Interventions
investigational material(s)
Generic name etc : ASTX660
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
Otsuka Pharmaceutical Co., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with T-cell lymphoma with histological diagnosis based on WHO classification (2017) 2) Patients with evaluable lesions. 3) Patients with ECOG PS score of 0 or 1. 4) Patients with adequate organ functions as shown below. a) AST and ALT 2.0xULN or less (3.0xULN or less if liver infiltration is present) b) Total bilirubin 1.5xULN or less c) ANC 1,000/mm3 or more (750/mm3 or more if bone marrow infiltration is present) d) Platelet count 50,000/mm3 or more (25,000/mm3 or more if bone marrow infiltration is present) e) Serum creatinine 1.5xULN or less or creatinine clearance 50 mL/min or more f) Amylase and lipase 1.0xULN or less
Exclusion criteria
Exclusion criteria: 1) Patients with active infection requiring treatment with antibiotics, antifungals, or antivirals 2) Patients with heart disease that meets the followings: a) LVEF of < 50% by echocardiography or MUGA scan b) Congestive heart failure (NYHA classification 3 or 4) c) Uncontrolled heart disease including unstable angina pectoris or hypertension considered to require hospitalization within last 3 months (90 days) d) Complete left bundle branch block, 3 degree (complete) atrioventricular block, use of pacemaker, history or complication of poorly controlled arrhythmia requiring treatment e) History or complication of long QT syndrome f) History or complication of ventricular arrhythmia requiring active treatment g) Corrected QT interval of 470 or more msec based on 12-lead ECG performed at the screening h) Concern on increased cardiac risk by participating in the study based on medical judgment 3) Patients receiving the following treatment for the primary disease prior to the initial dose of study drug a) Chemotherapy or radiotherapy within last 3 weeks b) Skin directed therapy including local treatment or phototherapy within last 3 weeks c) Treatment with monoclonal antibody within last 4 weeks d) Treatment with other study drugs or study treatment within last 3 weeks or 5 half-lives, whichever is longer 4) Patients with prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 14 weeks prior to the day of initial dose of study drug 5) Patients who have received corticosteroids at a dose exceeding a prednisone equivalent dose of 10 mg/day within 3 weeks prior to the initial dose of study drug. 6) Patients with Inadequately controlled diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Phase I part(dose-escalation part):Dose Limiting Toxicity,Safety Phase I part(ATLL expansion part):Safety Phase II part:Overall response rate(ORR)by the Central Data Review Committee | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics Phase I part (dose-escalation part and ATLL expansion part): Pharmacokinetics, Efficacy, pharmacodynamics Phase II part: Efficacy, Safety, Pharmacokinetics | — |
Countries
Japan
Outcome results
None listed