EDO-S101 Phase I study for Japanese patients with relapsed/refractory hematological malignancy

Phase 1

Completed

• Conditions: Relapsed/refractory Hodgkin's lymphoma, Non-Hodgkin's lymphoma, Multiple myeloma

• Registration Number: JPRN-jRCT2080224049
• Lead Sponsor: MUNDIPHARMA K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-15
• Study Completion: 2021-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 15

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified