Aroplatin and Gemcitabine in Patients With Advanced Pancreatic Cancer Resistant to Standard Therapies
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the
maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®)
in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase
II, the primary objective is to evaluate survival after therapy with Aroplatin and
gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or
metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity
of adverse events and determine the proportion of non-progressors and the progression-free
interval.