A phase 1 Multiple Ascending Dose Study of DS-3201b in Subjects with Lymphomas
Phase 1
Completed
- Conditions
- Relapsed non-hodgkin lymphoma
- Registration Number
- JPRN-jRCT2080223118
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 100
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>other<br>Safety and pharmacokinetics<br>-The safety of DS-3201b will be assessed by CTCAE<br>Pharmacokinetics of DS-3201b will be evaluated by following the instruction of the study protocol.<br>Drug-Drug interaction (DDI)<br>- 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 Outcome Measures
Name Time Method safety<br>efficacy<br>- The maximum tolerated dose<br>- Assessment of tumor response of malignant lymphoma, ATL, CTCL.<br>- the safety and tolerability of DS-3201b when administered alone or in combination with a single dose of CYP3A and P-gp.<br><br>Tumor response will be evaluated by following the instruction of the study protocol.