A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
Phase 2
Suspended
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00536770
- Lead Sponsor
- Novacea
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Placebo + gemcitabine Placebo + gemcitabine B placebo + gemcitabine + erlotinib Placebo + gemcitabine + erlotinib C calcitriol + gemcitabine DN-101 + gemcitabine D calcitriol + gemcitabine + erlotinib DN-101 + gemcitabine + erlotinib
- Primary Outcome Measures
Name Time Method Overall survival rate at 6 months
- Secondary Outcome Measures
Name Time Method Duration of overall survival Objective response rate Duration of progression free survival
Trial Locations
- Locations (1)
Novacea Investigational Site
🇺🇸Nashville, Tennessee, United States