♦Basic information
JapicCTI-No. JapicCTI-142693
♦Title of the study
Title of the study A phase 1 Multiple Ascending Dose Study of DS-3032b, an Oral MDM2 Inhibitor, in Japanese Subjects with Advanced Solid Tumors or Lymphomas
Public title of the study Phase 1 study of DS-3032b
Primary sponsor DAIICHISANKYO Co.,Ltd.
Secondary sponsor  
Study Type interventional (drug)
Summary This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of DS-3032b in Japanese subjects with advanced solid tumors or lymphomas
♦Details of the study
Disease or condition Advanced solid tumors or lymphomas that are refractory to standard therapy or for which no standard therapy is available.
Intervention
Intervention name DS-3032b
Classification name(code) of the intervention 429 (other antitumor agents)
Dosage And administration of the intervention Oral administration
Control intervention name  
Classification name(code) of the control intervention  
Dosage And administration of the control intervention  
Objectives of the study Treatment
Study phase Phase 1
Study design Multicenter, open-label
Target sample size 22
Inclusion Criteria - Advanced solid tumors or lymphomas that are refractory to standard therapy or for which no standard therapy is available.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

AgeF     20years old or more
SexF     Both
Exclusion Criteria - Previously had or currently has any of the following diseases:
Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral bypass surgery, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
- Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
- Severe or uncontrolled concomitant disease.
- Clinically active brain metastases, which are symptomatic or requiring treatment.
- Has a second concurrent primary malignancy such as solid tumor or lymphoma.


Outcome
Primary Outcome Safety, tolerability, and pharmacokinetics
Timepoints -The safety of DS-3032b will be assessed by CTCAE.
-The maximum tolerated dose of DS-3032b, and the recommended dose of DS-3032b for the following clinical studies will be estimated.
-Pharmacokinetics of DS-3032b will be evaluated by following the instruction of the study protocol.
Secondary Outcome -Pharmacodynamic effect of DS-3032b.
-Exploratory assessment of tumor or hematologic response.
-Exploratory assessment of the relationship between tumor response to DS-3032b and predictive biomarkers.
Timepoints -Pharmacodynamic effect of DS-3032b and exploratory assessment of DS-3032b-related biomarkers will be assessed by analysis of samples collected from subjects based on the study protocol schedule.
-Tumor response will be assessed by RECIST ver 1.1 or revised IWG criteria.
Institutions
Duration of the study 2014-11-1  `  2017-3-31
Study status In practice
recruitment status Recruiting closed - ongoing study
Region Japan
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization DAIICHISANKYO Co.,Ltd.
Division Contact for Clinical Trial Information
Contact person or e-mail address etc. http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html
Organization@(Scientific)
Division@(Scientific)
Contact person or e-mail address etc.@(Scientific)
♦Other
Source funded
Name of research funds
Other
♦History
History
2017/2/13   revised
2016/1/15   revised
2014/12/25   revised
2014/11/4   application date