Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors
Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability,
identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your
body does to process the drugs and how your body gets them out of your system.) and
pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body)
properties in subjects with advanced solid malignant tumors. This study will include 2 parts:
part 1-Dose Escalation and part 2-Dose Expansion.
Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy
properties in subjects with advanced solid malignant tumors for whom standard therapy has
failed or for whom no standard therapy exists.