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

Primary Purpose

Pancreatic Cancer

Status
Suspended
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
placebo + gemcitabine + erlotinib
Placebo + gemcitabine
calcitriol + gemcitabine
calcitriol + gemcitabine + erlotinib
Sponsored by
Novacea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novacea Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

D

Arm Description

Placebo + gemcitabine

Placebo + gemcitabine + erlotinib

DN-101 + gemcitabine

DN-101 + gemcitabine + erlotinib

Outcomes

Primary Outcome Measures

Overall survival rate at 6 months

Secondary Outcome Measures

Objective response rate
Duration of progression free survival
Duration of overall survival

Full Information

First Posted
September 26, 2007
Last Updated
November 2, 2007
Sponsor
Novacea
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00536770
Brief Title
A Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Patients With Advanced Pancreatic Cancer
Official Title
A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Suspended
Why Stopped
DSMB
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novacea
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Placebo + gemcitabine
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo + gemcitabine + erlotinib
Arm Title
C
Arm Type
Active Comparator
Arm Description
DN-101 + gemcitabine
Arm Title
D
Arm Type
Active Comparator
Arm Description
DN-101 + gemcitabine + erlotinib
Intervention Type
Drug
Intervention Name(s)
placebo + gemcitabine + erlotinib
Intervention Type
Drug
Intervention Name(s)
Placebo + gemcitabine
Intervention Type
Drug
Intervention Name(s)
calcitriol + gemcitabine
Intervention Type
Drug
Intervention Name(s)
calcitriol + gemcitabine + erlotinib
Primary Outcome Measure Information:
Title
Overall survival rate at 6 months
Secondary Outcome Measure Information:
Title
Objective response rate
Title
Duration of progression free survival
Title
Duration of overall survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Novacea Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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