Relapsed/refractory Hodgkin's lymphoma, Non-Hodgkin's lymphoma, Multiple myeloma
Conditions
Interventions
investigational material(s)
Generic name etc : EDO-S101
INN of investigational material : Tinostamustine
Therapeutic category code : 421 Alkylating agents
Dosage and Administration for Investigational
Sponsors
MUNDIPHARMA K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients histologically diagnosed with the following hematologic malignancies; Hodgkin's lymphoma, Non-Hodgkin's lymphoma, Multiple myeloma - Relapsed/refractory patients with a treatment history of at least one standard regimen - Patients with an measurable disease confirmed - Patients with ECOG PS 0-2 - Patients with adequate capacity/function of each organs - Japanese patients who has given written informed consent prior to study initiation
Exclusion criteria
Exclusion criteria: - Patients who received a chemotherapy, molecular target drug, biologics, radiotherapy, and/or immunotherapy within 28 days prior to the initial administration of the study drug, or who have not completely recovered from the toxicities of such prior therapies with unstable medical conditions - Patients who received other study drugs within 30 days prior to the initial administration of the study drug - Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to the initial administration of the study drug - Patients who have been treated with fludarabine or cladribine - Patients with QTcF >450 msec according to the results of ECG performed during screening period - Patients with severe cerebrovascular and cardiovascular disease - Patients who tested positive for HBs antigen or HIV antibody or patients who tested positive for either HBc antibody or HBs antibody, and showed HBV DNA levels above the upper limit of quantification for the assay. Or patients who tested positive for HCV antibody, and showed HCV RNA levels above the upper limit of quantification for the assay. - Pregnant women, lactating women, or women who may be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics Tolerability, safety and pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Efficacy | — |
Countries
Japan
Outcome results
None listed