B-cell non-Hodgkin`s lymphoma
Conditions
Interventions
To determine the clinically recommended dose of zandelisib by investigating the safety and tolerability of zandelisib (45 mg, 60 mg) in an open-label, dose-escalation study.
To continue administraion
Sponsors
Kyowa Kirin Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 20 years or older at the submission of the written informed consent form - Patients with relapsed or refractory B-cell NHL - Patients who have not undergone phosphatidylinositol 3-kinase inhibitor (PI3K) to date. - Patients who have undergone Bruton's tyrosine kinase (BTK) inhibitors and have had no exacerbation during the use of BTK inhibitors. - Patients with ECOG PS 0 or 1. - Patients who treated with ME-401 and acieved response of SD or better by IRRC tumor assessment in ME-401-004 study.
Exclusion criteria
Exclusion criteria: - Patients who underwent any major surgical treatment within 4 weeks prior to the initiation of the investigational product. - Patients with poorly controlled diseases. The followings are the examples but the diseases will not be limited to those. - Patients in whom any of HBV antigen/antibody, HCV antibody, HIV antibody or HTLV-1 antibody will be positive at screening test. - Patients with active interstitial lung disease or a history thereof. - Patients who have received the investigational products other than ME-401, systemic chemotherapy or radiotherapy within 4 weeks prior to the initiation of ME-401. - Patients who have experienced adverse events related to ME-401 and been considered to be ineligible to participate in this study by physician. - Patients with diseases not suitable for treatment with ME-401, for example, active interstitial lung disease and inflammatory bowel disease. - Patients who have been treated or prevented CMV within the past 28 days. - Patients who plan to participate in other clinical trials while receiving ME-401 in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - Adverse events - Laboratory test values - Vital signs - Electrocardiogram (ECG) (To subjects for DLT evaluation) (roll over study) Safety - Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Subjects for DLT evaluation) - Plasma concentration level of ME-401 - PK parameter Efficacy (Subjects for DLT evaluation) - Anti-tumor effect - Duration of response (DOR) - Progression-free survival (PFS) - Time to response (TTR) | — |
Countries
Japan
Outcome results
None listed