A Randomized, Open-Label Phase 2 Study of 2 Regimens, Gemcitabine Plus Enzastaurin and Single-Agent Gemcitabine, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Eli Lilly and Company1 site in 1 country130 target enrollmentDecember 2005

ConditionsPancreatic Neoplasm

Interventionsenzastaurin gemcitabine

Drugsenzastaurin gemcitabine

Overview

Phase: Phase 2
Intervention: enzastaurin
Conditions: Pancreatic Neoplasm
Sponsor: Eli Lilly and Company
Enrollment: 130
Locations: 1
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

May 2008

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Enzastaurin+Gemcitabine

Intervention: enzastaurin

Enzastaurin+Gemcitabine

Intervention: gemcitabine

Gemcitabine

Intervention: gemcitabine

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: Randomization to the date of death from any cause up to 27.7 months

OS was the duration from randomization to death. OS was censored at the last contact for participants who were alive, at the cut-off date.

Secondary Outcomes

Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)(Randomization to measured progressive disease (PD) up to 19.9 months)
Change in Scores From Baseline (Improved, Stable or Worsened) to End of Study in Functional Assessment of Cancer Therapy Hepatobiliary Version 4 ( FACT-Hep v.4) (Quality of Life (QOL))(Baseline through end of study up to 27.7 months)
Carbohydrate Antigen 19-9 (CA 19-9) Concentration in the Blood(Cycles 1 to 6, and post-treatment (up to 27.7 months))
Progression Free Survival (PFS)(Randomization to measured PD or death from any cause up to 21.6 months)
Duration of Response(Time of response to PD or death from any cause up to 19.9 months)
Relationship of Steady-State Drug Levels to Clinical Outcomes of Overall Survival (OS)(Randomization to date of death from any cause up to 27.7 months)
Relationship of Steady-state Drug Levels to Best Overall Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Disease Control)(Beginning of treatment up to 27.7 months)
Number of Participants Experiencing Serious Adverse Events (SAEs) and Adverse Events (AEs) (Toxicity)(Baseline through study completion (Up To 27.7 Months))