A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

The purpose of this study is to determine the safety and efficacy of an investigational study drug DN-101 (calcitriol) when given in combination with gemcitabine ± erlotinib in the treatment of pancreatic cancer.

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of locally advanced and unresectable, or metastatic pancreatic cancer
• Performance status 0, 1,or 2
• Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Prior chemotherapy or radiation therapy for pancreatic cancer
• Prior treatment for other cancers in last 6 months
• Cancer of the brain or spine
• Active uncontrolled infection
• Hypercalcemia