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A Study of LY3076226 in Participants With Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02529553
Recruitment Status : Completed
First Posted : August 20, 2015
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Metastatic Cancer Drug: LY3076226 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of LY3076226, a Fibroblast Growth Factor Receptor 3 (FGFR3) Antibody-Drug Conjugate, in Patients With Advanced or Metastatic Cancer
Study Start Date : September 2015
Actual Primary Completion Date : March 28, 2018
Actual Study Completion Date : March 28, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: LY3076226

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.

Drug: LY3076226
Administered IV

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of LY3076226 [ Time Frame: Cycle 1 (21 Days) ]
    The MTD was defined as the highest dose tested that had less than 33% probability of causing a dose limiting toxicity (DLT).

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Number of Participants With Tumor Response [ Time Frame: Baseline through Study Completion (Cycle 3, day 21) ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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: 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02529553

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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
The START Center for Cancer Care
San Antonio, Texas, United States, 78229
Canada, British Columbia
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, V5Z 4E6
Sponsors and Collaborators
Eli Lilly and Company
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Study Director: 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) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] August 6, 2015
Statistical Analysis Plan  [PDF] June 24, 2015

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eli Lilly and Company Identifier: NCT02529553    
Other Study ID Numbers: 15383
I7O-MC-JOBA ( Other Identifier: Eli Lilly and Company )
First Posted: August 20, 2015    Key Record Dates
Results First Posted: April 17, 2020
Last Update Posted: April 17, 2020
Last Verified: April 2020
Keywords provided by Eli Lilly and Company:
bladder cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes