The main purpose of this study is to evaluate the safety of the study drug known as LY3076226 in participants with advanced or metastatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Administered IV
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The START Center for Cancer Care
San Antonio, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Vancouver, British Columbia, Canada
Maximum Tolerated Dose (MTD) of LY3076226
The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).
Time frame: Cycle 1 (21 Days)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
Time frame: Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Time frame: Predose: Day 1 (Cycle 1) and 63 (Cycle 3); Postdose: 0.05, 1, 3, 6, 24 and 72 hours
Number of Participants With Tumor Response
Tumor response was assessed using confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST version 1.1). Complete response (CR) was the disappearance of all target and non-target lesions and normalization of tumor marker levels of non-target lesions; partial response (PR) was at least a 30% decrease in the sum of the longest diameter of target lesions.
Time frame: Baseline through Study Completion (Cycle 3, day 21)
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