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

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: A
    Placebo + gemcitabine
  • Placebo Comparator: B
    Placebo + gemcitabine + erlotinib
  • Active Comparator: C
    DN-101 + gemcitabine
  • Active Comparator: D
    DN-101 + gemcitabine + erlotinib

Primary Outcome Measure

Overall survival rate at 6 months

Locations (1)

FacilityCityStateZIPSite coordinators
Novacea Investigational SiteNashvilleTennessee--

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