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

Paused · Phase 2 · Has a placebo group

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00536770

Run by

Novacea

People needed

132

Starts

2007-09-01

Last updated by the study team

2007-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novacea Investigational Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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