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SuspendedNCT00536770Updated Nov 6, 2007

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

A Phase 2 interventional study of placebo + gemcitabine + erlotinib and Placebo + gemcitabine in Pancreatic Cancer, sponsored by Novacea. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-06.

Sponsored by Novacea · Phase 2, Interventional, and Treatment

Why this study was suspended
DSMB
Phase
Phase 2
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's planned enrollment of 132 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Novacea is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
132 participants (estimated)

Study arms

  • 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

Interventions

  • Drugplacebo + gemcitabine + erlotinib
  • DrugPlacebo + gemcitabine
  • Drugcalcitriol + gemcitabine
  • Drugcalcitriol + gemcitabine + erlotinib
06

What researchers measure

Primary outcomes

  1. Overall survival rate at 6 months

Secondary outcomes

  1. Objective response rate

  2. Duration of progression free survival

  3. Duration of overall survival

07

Study locations

1 site
  • Novacea Investigational Site
    Nashville, Tennessee, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00536770
Lead sponsor
Novacea
Collaborators
Schering-Plough
First posted
Sep 28, 2007
Start date
Sep 2007
Last update
Nov 6, 2007

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.

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