The main purpose of this study is to evaluate the safety and side effects of LY2157299 in combination with gemcitabine in Japanese participants with pancreatic cancer that is advanced or has spread to another part of the body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Administered orally
Administered IV
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.
Chiba, Japan
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.
Tokyo, Japan
Number of Participants with LY2157299 Dose-Limiting Toxicities (DLT)
Time frame: Cycle 1 (28 days)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2157299
Time frame: Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles)
PK: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2157299
Time frame: Cycle 1: Predose on Day 1 through Day 28, Cycle 2 through last cycle: Predose on Day 1 (Cycle = 28 days; treatment estimated to last 4 cycles)
PK: Cmax of Gemcitabine
Time frame: Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8
PK: AUC of Gemcitabine
Time frame: Cycle 1 (28 days): Predose on Day 8 through 2 hours after gemcitabine infusion on Day 8
Percentage of Participants with a Tumor Response
Time frame: Baseline to study completion (estimated as 5 months)
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