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Sponsors and Collaborators: |
Novacea Schering-Plough |
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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 |
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
|
Drug: Placebo + gemcitabine |
B: Placebo Comparator
Placebo + gemcitabine + erlotinib
|
Drug: placebo + gemcitabine + erlotinib |
C: Active Comparator
DN-101 + gemcitabine
|
Drug: calcitriol + gemcitabine |
D: Active Comparator
DN-101 + gemcitabine + erlotinib
|
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 |
Study First Received: | September 26, 2007 |
Last Updated: | November 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00536770 |
Health Authority: | United States: Food and Drug Administration |
Erlotinib Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Calcitriol Calcium, Dietary Digestive System Diseases |
Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Adenocarcinoma Gemcitabine Endocrine Gland Neoplasms |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Enzyme Inhibitors Bone Density Conservation Agents Cardiovascular Agents |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Membrane Transport Modulators Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Vitamins Vasoconstrictor Agents Micronutrients |