NCT00267020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
12.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2020

Completed
Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

2.4 years

First QC Date

December 16, 2005

Results QC Date

June 9, 2020

Last Update Submit

August 17, 2020

Conditions

Pancreatic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    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.

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

Secondary Outcomes (8)

  • Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Response Rate)

    Randomization to measured progressive disease (PD) up to 19.9 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Enzastaurin+Gemcitabine

EXPERIMENTAL
Drug: enzastaurinDrug: gemcitabine

Gemcitabine

ACTIVE COMPARATOR
Drug: gemcitabine

Interventions

enzastaurinDRUG

1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles

Also known as: LY317615
Enzastaurin+Gemcitabine
gemcitabineDRUG

1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles

Also known as: LY188011, Gemzar
Enzastaurin+GemcitabineGemcitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559), Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician

Dallas, Texas, United States

Location

Related Publications (1)

  • Yount S, Cella D, Webster K, Heffernan N, Chang C, Odom L, van Gool R. Assessment of patient-reported clinical outcome in pancreatic and other hepatobiliary cancers: the FACT Hepatobiliary Symptom Index. J Pain Symptom Manage. 2002 Jul;24(1):32-44. doi: 10.1016/s0885-3924(02)00422-0.

    PMID: 12183093BACKGROUND

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

enzastaurinGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 20, 2005

Study Start

December 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

August 31, 2020

Results First Posted

August 31, 2020

Record last verified: 2020-08

Locations

US(1)