A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Novacea
- Study ID
- NCT00536770
- Phase
- PHASE2
- Status
- Suspended
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- placebo + gemcitabine + erlotinib — DRUG
- Placebo + gemcitabine — DRUG
- calcitriol + gemcitabine — DRUG
- calcitriol + gemcitabine + erlotinib — DRUG
Study Details
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 Dates
- First listed
- Sep 28, 2007
- Start date
- Sep 30, 2007
- Status verified
- Nov 2007
Study Design
- Enrollment
- 132 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: APlacebo + gemcitabine
- Placebo Comparator: BPlacebo + gemcitabine + erlotinib
- Active Comparator: CDN-101 + gemcitabine
- Active Comparator: DDN-101 + gemcitabine + erlotinib
Primary Outcome Measure
Overall survival rate at 6 months
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Novacea Investigational Site | Nashville | Tennessee | - | - |
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