Phase 1 study of DS-6051b
- Conditions
- Advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene
- Registration Number
- JPRN-jRCT2080223057
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 15
Advanced solid malignant tumors 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
-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 artery disease, 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 or central nervous system tumor requiring steroid or anticonvulsant treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety, tolerability, and pharmacokinetics<br>-The safety of DS-6051b will be assessed by CTCAE.<br>-The maximum tolerated dose of DS-6051b, and the recommended dose of DS-6051b for the following clinical studies will be estimated.<br>-Pharmacokinetics of DS-6051b will be evaluated by following the instruction of the study protocol.
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>The maximum tolerated dose, the recommended dose of for the following clinical studies, pharmacokinetics, exploratory assessment of tumor response<br>Tumor response will be assessed by RECIST