Clinical Trials/NCT00536770

NCT00536770

Suspended

Phase 2

A Randomized Phase 2 Study of Gemcitabine ± Erlotinib and DN-101 Versus Gemcitabine ± Erlotinib and Placebo in Subjects With Advanced Pancreatic Adenocarcinoma

Novacea1 site in 1 country132 target enrollmentSeptember 2007

ConditionsPancreatic Cancer

Interventionsplacebo + gemcitabine + erlotinib Placebo + gemcitabine calcitriol + gemcitabine calcitriol + gemcitabine + erlotinib

Drugsplacebo + gemcitabine + erlotinib Placebo + gemcitabine calcitriol + gemcitabine calcitriol + gemcitabine + erlotinib

Overview

Phase: Phase 2
Intervention: placebo + gemcitabine + erlotinib
Conditions: Pancreatic Cancer
Sponsor: Novacea
Enrollment: 132
Locations: 1
Primary Endpoint: Overall survival rate at 6 months
Status: Suspended
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Arms & Interventions

B

Placebo + gemcitabine + erlotinib

Intervention: placebo + gemcitabine + erlotinib

A

Placebo + gemcitabine

Intervention: Placebo + gemcitabine

C

DN-101 + gemcitabine

Intervention: calcitriol + gemcitabine

D

DN-101 + gemcitabine + erlotinib

Intervention: calcitriol + gemcitabine + erlotinib

Outcomes

Primary Outcomes

Overall survival rate at 6 months

Secondary Outcomes

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

Study Sites (1)

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