4 results
The objectives of this study are to:- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 21 days per dosing cycle.- Evaluate the pharmacokinetics of gemcitabine and 2', 2'-difluorodeoxyuridine (dFdU, a…
The primary objective of this investigation is to assess the performance of the ANSeR Software System by quantifying and comparing the diagnostic accuracy of investigation personnel using the ANSeR Software System with the diagnostic accuracy of…
- Evaluate the safety and tolerability of up to 2 dosing cycles of GemRIS for up to 7 days per dosing cycle - Evaluate the pharmacokinetics of gemcitabine and 2',2'-difluorodeoxyuridine (dFdU, a gemcitabine-related metabolite) exposure in…
Part 1 (Dose Escalation) - to identify the recommended Phase 2 dose(s) and schedule(s) to be safe for JNJ-79635322. Part 2 (Dose Expansion) is to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s).