NCT00055250

Brief Summary

The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine in patients 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 pancreatic-cancer

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

February 21, 2003

Last Update Submit

January 24, 2007

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • 6-month survival

Secondary Outcomes (3)

  • Toxicity

  • tumor response

  • PK

Interventions

GemcitabineDRUG
LY293111DRUG
placeboDRUG

Eligibility Criteria

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

You may qualify if:

  • Adenocarcinoma of the pancreas that is locally advanced or metastatic and not amenable to resection with curative intent
  • Tumor that can be measured by x-ray or scan
  • Adequate organ function

You may not qualify if:

  • Inability to swallow capsules
  • Documented brain metastases
  • Prior chemotherapy or biological therapy for this disease

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 from 9AM to 5pm Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Lakeland, Florida, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineLY 293111

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 21, 2003

First Posted

February 24, 2003

Study Start

January 1, 2003

Study Completion

October 1, 2005

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

US(1)