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.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||Start Date: September 2015||Phase 1||Interventional|
Primary Outcome 1 - Measure: Maximum Tolerated Dose (MTD) of LY3076226
Primary Outcome 1 - Time Frame: Cycle 1 (21 Days)
- Have advanced or metastatic cancer and be an appropriate candidate for experimental
- Part B: Have a diagnosis of bladder cancer.
- Part B: Have alterations of FGFR3.
- Have adequate organ function.
- Have discontinued previous treatments for cancer and have resolution, except where
otherwise stated in the inclusion criteria, of all clinically significant toxic
effects of prior chemotherapy, surgery, or radiotherapy to Grade ≤1 by National Cancer
Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 (v
- If participant is of reproductive potential, must agree to use medically approved
contraceptive precautions during the study and for 3 months following the last dose of
study drug. If the participant is a female of childbearing potential, must have had a
negative serum or urine pregnancy test within 7 days of the first dose of study drug
and must not be breastfeeding.
- Have received treatment within 28 days of the initial dose of study drug with an
investigational product or non-approved use of a drug or device (other than the study
drug/device used in this study) or are concurrently enrolled in any other type of
medical research judged not to be scientifically or medically compatible with this
- Have preexisting corneal disease that may interfere with assessment for potential eye
toxicity during the study.
- Have preexisting Grade ≥2 skin disorder (for example, erythema, dermatitis).
- Have serious preexisting medical conditions (left to the discretion of the
- Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
required). Participants with treated CNS metastases are eligible for this study if
they are not currently receiving corticosteroids and/or anticonvulsants, and their
disease is asymptomatic and radiographically stable for at least 28 days.
- Have current acute or chronic leukemia.
- Have an active fungal, bacterial, and/or known viral infection including human
immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis (screening is not
- Have a second primary malignancy that, in the judgment of the investigator and
sponsor, may affect the interpretation of results. Curatively treated nonmelanoma skin
cancer or in situ carcinoma of any origin is allowed.
- Have Fridericia-corrected QT interval (QTcF) >480 milliseconds on screening
- Have a serious cardiac condition, such as congestive heart failure; New York Heart
Association Class III/IV heart disease; unstable angina pectoris; myocardial
infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed
clinically significant; or arrhythmias that are symptomatic or require treatment (not
including participants with rate-controlled atrial fibrillation).
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: 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)
Role: Study Director
Affiliation: Eli Lilly and Company
Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
|Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111-2497
|Medical University of South Carolina
Charleston, South Carolina 29425
|The START Center for Cancer Care
San Antonio, Texas 78229
|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 V5Z 4E6
Eli Lilly and Company