臨床研究等提出・公開システム

A phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects with Lymphomas

A phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects with Lymphomas

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

completed

Mar. 31, 2016

Interventional

Multi Center, Open label study

treatment purpose

1

- 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

- 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

Both

Relapsed non-hodgkin lymphoma

investigational material(s)
Generic name etc : Valemetostat tosylate
INN of investigational material : Valemetstat tosylate
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Oral administration

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

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.

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.

Mar. 14, 2016