A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
Phase I Primary Objective:
- Determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and
gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic
Phase II Primary Objective:
- Evaluate survival after therapy with Aroplatin and gemcitabine at the MTD in subjects
with unresectable, locally advanced and/or metastatic pancreatic cancer.
Phase II Secondary Objective:
- Evaluate the severity and quantity of adverse events and determine the proportion of
non-progressors and the progression-free interval.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration