Description:
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.
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.
Completed
Phase 1
NCT ID: NCT02529553
ORG ID: 15383
NCI ID: I7O-MC-JOBA
Advanced Cancer
Metastatic Cancer
Drug | Synonyms | Arms |
---|---|---|
LY3076226 | LY3076226 |
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.
Name | Type | Description | Interventions |
---|---|---|---|
LY3076226 | Experimental | Part A (dose escalation in advanced cancer): LY3076226 administered intravenously (IV) on day 1 of each 21 day cycle. Part B (dose expansion in advanced urothelial carcinoma): LY3076226 administered IV on day 1 of each 21 day cycle. Part C (dose expansion in other malignancies): LY3076226 administered IV on day 1 of each 21 day cycle. | LY3076226 |
Inclusion Criteria:
- Have advanced or metastatic cancer and be an appropriate candidate for experimental
therapy.
- Part B: Have a diagnosis of bladder cancer.
- Part B and C: 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 4.0).
- 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.
Exclusion Criteria:
- 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
study.
- 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
investigator).
- 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
required).
- 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
electrocardiogram (ECG).
- 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 Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Maximum Tolerated Dose (MTD) of LY3076226
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3076226
PK: Area Under the Concentration-Time Curve (AUC) of LY3076226
Number of Participants with Tumor Response
bladder cancer