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

Novacea

Status and phase: Suspended; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: calcitriol + gemcitabine + erlotinib; Drug: calcitriol + gemcitabine; Drug: Placebo + gemcitabine; Drug: placebo + gemcitabine + erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536770

011-017

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 4 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Placebo + gemcitabine

Treatment:

Drug: Placebo + gemcitabine

B

Placebo Comparator group

Description:

Placebo + gemcitabine + erlotinib

Treatment:

Drug: placebo + gemcitabine + erlotinib

C

Active Comparator group

Description:

DN-101 + gemcitabine

Treatment:

Drug: calcitriol + gemcitabine

D

Active Comparator group

Description:

DN-101 + gemcitabine + erlotinib

Treatment:

Drug: calcitriol + gemcitabine + erlotinib