Phase 2 Study of Gemcitabine or Gemcitabine + Enzastaurin in Participants With Advanced or Metastatic Pancreatic Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasm

Treatments: Drug: gemcitabine; Drug: enzastaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00267020

H6Q-US-S002 (Other Identifier)

10463

Details and patient eligibility

About

The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of adenocarcinoma of the pancreas.
• Pretreatment tumor specimen must be available.
• No prior chemotherapy immunotherapy, biological therapy, or hormonal therapy for pancreatic cancer, including 5-fluorouracil (5-FU) with radiation therapy.
• Prior radiation allowed.
• Ability to stop some types of anti-seizure medicines within 14 days of enrollment.

Exclusion criteria

• Endocrine pancreatic tumor or ampullary cancer.
• Central Nervous System (CNS) metastases.
• Inability to swallow tablets.
• 10% or greater weight loss over the 6 weeks before study entry.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Enzastaurin+Gemcitabine

Experimental group

Treatment:

Drug: enzastaurin

Drug: gemcitabine

Gemcitabine

Active Comparator group

Treatment:

Drug: gemcitabine