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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.
(DSMB)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00536770
First Posted: September 28, 2007
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by:
Novacea
September 26, 2007
September 28, 2007
November 6, 2007
September 2007
Not Provided
Overall survival rate at 6 months
Same as current
Complete list of historical versions of study NCT00536770 on ClinicalTrials.gov Archive Site
  • Objective response rate
  • Duration of progression free survival
  • Duration of overall survival
Same as current
Not Provided
Not Provided
 
A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pancreatic Cancer
  • Drug: placebo + gemcitabine + erlotinib
  • Drug: Placebo + gemcitabine
  • Drug: calcitriol + gemcitabine
  • Drug: calcitriol + gemcitabine + erlotinib
  • Placebo Comparator: A
    Placebo + gemcitabine
    Intervention: Drug: Placebo + gemcitabine
  • Placebo Comparator: B
    Placebo + gemcitabine + erlotinib
    Intervention: Drug: placebo + gemcitabine + erlotinib
  • Active Comparator: C
    DN-101 + gemcitabine
    Intervention: Drug: calcitriol + gemcitabine
  • Active Comparator: D
    DN-101 + gemcitabine + erlotinib
    Intervention: Drug: calcitriol + gemcitabine + erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
132
Not Provided
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00536770
011-017
No
Not Provided
Not Provided
Not Provided
Novacea
Schering-Plough
Not Provided
Novacea
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP