Status:
COMPLETED
A Study for Participants With Pancreatic Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the Phase 1 portion of this study was to determine the dose of LY2603618 that can be safely administered 24 hours after gemcitabine treatment. This dose was then used for the Phase 2 po...
Detailed Description
Phase 1 included a dose escalation of LY2603618 doses from 70 milligrams/meter squared (mg/m\^2) to 250 mg/m\^2 divided into 5 cohorts. Each participant was assigned to a single cohort with no intra-p...
Eligibility Criteria
Inclusion
- Diagnosed with cancer that is metastatic and/or advanced during Phase 1
- Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery
- Must be at least 18 years of age
- Adequate hematological, liver, and renal functions
- Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
Exclusion
- Known hypersensitivity to gemcitabine
- Pregnant or lactating females or refusal to use medically approved contraceptive precautions
- Had prior treatment with radiotherapy involving more than 25% of marrow producing area
- Have received treatment in the last 30 days with a drug which has not received regulatory approval for any indication at the time of study entry
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00839332
Start Date
February 1 2009
End Date
December 1 2013
Last Update
April 17 2018
Active Locations (30)
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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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville, Florida, United States, 32224
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Athens, Georgia, United States, 30607
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Macon, Georgia, United States, 31201
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Post Falls, Idaho, United States, 83854