A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT02529553|
Recruitment Status : Completed
First Posted : August 20, 2015
Results First Posted : April 17, 2020
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Metastatic Cancer||Drug: LY3076226||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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 [ 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02529553
|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|
|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|