Relapsed non-hodgkin lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : Valemetostat tosylate
INN of investigational material : Valemetstat tosylate
Therapeutic category code : 429 Other antitumor agents
Dosage and Administra
Sponsors
DAIICHI SANKYO CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Has a pathologically documented non hodgkin's lymphoma (NHL) - Has relapsed from or is refractory to standard treatment or for which no standard treatment is available. - Has an ECOG PS 0-1 - >=18 years in the US, >=20 years in Japan
Exclusion criteria
Exclusion criteria: - Previously had or currently has any of the following diseases: (within 6 months before registration) uncontrolled diabetes, symptomatic congestive heart failure (NYHA classes III-IV), unstable angina, myocardial infarction, arrhythmia requiring treatment - Active tuberculous diseases, herpes simplex, or systemic mycosis requiring treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics other Safety and pharmacokinetics - The safety of DS-3201b will be assessed by CTCAE Pharmacokinetics of DS-3201b will be evaluated by following the instruction of the study protocol. Drug-Drug interaction (DDI) - The Pharmacokinetics of index substrate for cytochrome P450 3A [CYP3A] and P-glycoprotein [P-gp] substrate when co-administered with DS-3201b will be assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - The maximum tolerated dose - Assessment of tumor response of malignant lymphoma, ATL, CTCL. - the safety and tolerability of DS-3201b when administered alone or in combination with a single dose of CYP3A and P-gp. Tumor response will be evaluated by following the instruction of the study protocol. | — |
Countries
Japan, United States
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed