A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer
18 Years
85 Years
Both
Pancreatic Neoplasms
Trial Information
A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer
Phase 1 will be a dose escalation of doses 70 mg/m2 to 300 mg/m2 divided into 6 cohorts.
Each patient will be assigned to a single cohort with no intrapatient dose escalation.
Patients will received gemcitabine on days 1, 8, and 15 followed by LY2603618 on days 2, 9,
and 16 of each 28 day cycle. The phase 1 portion will enroll approximately 26 patients
total to determine the maximum tolerated dose to be carried into the phase 2 portion of the
study.
Inclusion Criteria:
- 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 18 years of age
- Adequate hematological, liver, and renal functions
- ECOG status 0-2
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1: Determine the maximum tolerated dose for LY2603618 when administered after gemcitabine.
Outcome Time Frame:
Time of first dose until 28 days post dose
Safety Issue:
Yes
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
United States: Food and Drug Administration
Study ID:
12096
NCT ID:
NCT00839332
Start Date:
March 2009
Completion Date:
August 2013
Related Keywords:
- Pancreatic Neoplasms
- Pancreas
- metastatic cancer
- advanced cancer
- Pancreatic cancer
- Neoplasms
- Pancreatic Neoplasms
Name | Location |
|---|---|
| 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. | Iowa City, Iowa |
| 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 32256 |
| 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 30607 |
| 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. | Kalamazoo, Michigan 49048 |
| 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. | Minneapolis, Minnesota 55404 |
| 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. | Dunmore, Pennsylvania 18512 |
| 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. | Memphis, Tennessee 38138 |
| 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. | Bedford, Texas 76022 |
| 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. | Norfolk, Virginia 23502 |
| 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. | Marshfield, Wisconsin 54449 |
| 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. | Coeur D'Alene, Idaho 83814 |
| 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. | Fargo, North Dakota 58122 |
| 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. | Sioux Falls, South Dakota 57104 |
