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A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer

This study has suspended participant recruitment.
Information provided by:
Novacea Identifier:
First received: September 26, 2007
Last updated: November 2, 2007
Last verified: November 2007
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Novacea:

Primary Outcome Measures:
  • Overall survival rate at 6 months

Secondary Outcome Measures:
  • Objective response rate
  • Duration of progression free survival
  • Duration of overall survival

Estimated Enrollment: 132
Study Start Date: September 2007
Arms Assigned Interventions
Placebo Comparator: A
Placebo + gemcitabine
Drug: Placebo + gemcitabine
Placebo Comparator: B
Placebo + gemcitabine + erlotinib
Drug: placebo + gemcitabine + erlotinib
Active Comparator: C
DN-101 + gemcitabine
Drug: calcitriol + gemcitabine
Active Comparator: D
DN-101 + gemcitabine + erlotinib
Drug: calcitriol + gemcitabine + erlotinib


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00536770

United States, Tennessee
Novacea Investigational Site
Nashville, Tennessee, United States
Sponsors and Collaborators
  More Information Identifier: NCT00536770     History of Changes
Other Study ID Numbers: 011-017
Study First Received: September 26, 2007
Last Updated: November 2, 2007

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents processed this record on September 20, 2017