Pancreatic Neoplasms Clinical Trial
Official title:
A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer
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.
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
pancreatic cancer.
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
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