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Sponsors and Collaborators: |
Novacea Schering-Plough |
Information provided by: | Novacea |
ClinicalTrials.gov Identifier: | NCT00536770 |
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.
Condition | Intervention | Phase |
Pancreatic Cancer |
Drug: placebo + gemcitabine + erlotinib Drug: Placebo + gemcitabine Drug: calcitriol + gemcitabine Drug: calcitriol + gemcitabine + erlotinib |
Phase II |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
Drug Information available for: | Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Calcitriol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma |
Estimated Enrollment: | 132 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
A: Placebo Comparator
Placebo + gemcitabine
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Drug: Placebo + gemcitabine |
B: Placebo Comparator
Placebo + gemcitabine + erlotinib
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Drug: placebo + gemcitabine + erlotinib |
C: Active Comparator
DN-101 + gemcitabine
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Drug: calcitriol + gemcitabine |
D: Active Comparator
DN-101 + gemcitabine + erlotinib
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Drug: calcitriol + gemcitabine + erlotinib |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 011-017 |
First Received: | September 26, 2007 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00536770 |
Health Authority: | United States: Food and Drug Administration |
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