The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor activity.
The study consists of two parts and these will be conducted sequentially: Part 1 (dose escalation) and Part 2 (dose expansion). Subjects will participate in Part 1 or Part 2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
oral
Site US10001
New Haven, Connecticut, United States
Site US10004
Chicago, Illinois, United States
Site US10002
Rochester, Minnesota, United States
Site US10003
Houston, Texas, United States
Site US10005
Safety as assessed by adverse events
Time frame: up to 39 months
Safety as assessed by clinical laboratory tests
Time frame: up to 39 months
Safety as assessed by vital signs
Time frame: up to 39 months
Safety as assessed by electrocardiograms (ECG)
Time frame: up to 39 months
Objective response rate to ASP4132
Time frame: Week 16
Duration of response to ASP4132
Time frame: Week 16
Disease control rate to ASP4132
Time frame: Week 16
Maximum concentration (Cmax) of ASP4132
Time frame: up to 43 days
Time of the maximum concentration (Tmax) of ASP4132
Time frame: up to 43 days
Area under the concentration-time curve from time of dosing to the last measurable concentration (AUClast) of ASP4132
Time frame: up to 43 days
AUC from the time of dosing to 24 hours (AUC24) of ASP4132
Time frame: up to 43 days
AUC from the time of dosing extrapolated to time infinity (AUCinf) of ASP4132
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fairfax, Virginia, United States
Time frame: up to 43 days
Apparent terminal elimination half-life (T1/2) of ASP4132
Time frame: up to 43 days
Accumulation ratio of ASP4132
Time frame: up to 43 days
Apparent total systemic clearance after single or multiple extravascular dosing (CL/F) of ASP4132
Time frame: up to 43 days
Apparent volume of distribution during the terminal elimination phase after single or multiple extravascular dosing (Vz/F) of ASP4132
Time frame: up to 43 days
Progression-free survival
Time frame: up to 39 months