Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors (NCT02675491) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors
Japan15 participantsStarted 2016-02-10
Plain-language summary
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.
Who can participate
Age range20 Years
SexALL
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Inclusion Criteria:
* 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.
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 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.