A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer
Both
Pancreatic Cancer
Trial Information
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall survival rate at 6 months
Authority:
United States: Food and Drug Administration
Study ID:
011-017
NCT ID:
NCT00536770
Start Date:
September 2007
Completion Date:
Related Keywords:
- Pancreatic Cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Novacea Investigational Site | Nashville, Tennessee |
