The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Study participation could last up to approximately 6 years, depending on which part of the study you join.
This is an open-label, multi-center, phase 1 study in participants with FGFR3-altered advanced solid tumor malignancy including metastatic urothelial cancer (UC), muscle-invasive bladder cancer (MIBC), and low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC). The study will be conducted in 2 phases. Phase 1a will assess safety, tolerability, and pharmacokinetics of Vepugratinib to determine the optimal dose for further expansion. Phase 1b will include dose expansion cohorts to evaluate the efficacy and safety of Vepugratinib as monotherapy or in combinations with other medicines that treat cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
677
University of Arizona - Cancer Center
Tucson, Arizona, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGUniversity of California, Los Angeles (UCLA) - Division of Hematology-Oncology
Los Angeles, California, United States
RECRUITINGUniversity of California - Irvine
Orange, California, United States
Overall Response Rate (ORR)
Time frame: Up to Approximately 30 Months or 2.5 Years
Pharmacokinetics (PK) of Vepugratinib: Area Under the Concentration versus Time Curve (AUC)
Time frame: Up to 2 Months
PK of Midazolam, Rosuvastatin, and Digoxin Administered Alone and in the Presence of Vepugratinib: Area Under the Concentration versus Time Curve (AUC[0-inf])
Time frame: Up to 2 Months
Complete Response Rate (CRR) in Participants with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC)
Time frame: Up to approximately 24 months or 5 years
Change from Baseline in Bladder-Related Symptoms, Measured by Functional Assessment of Cancer Therapy - Bladder (FACT-Bl) Subscale (BlCS)
Time frame: Cycle 1 Day 1, Cycle 2 Day 1, and Cycle 3 Day 1 (28 Day Cycles)
Change from Baseline in Physical Function, Measured by FACT- Physical Well-Being Scale (PWB) Subscale
Time frame: Up to Approximately 30 Months or 2.5 Years
Event-Free Survival (EFS) in Participants with Muscle Invasive Bladder Cancer (MIBC)
Time frame: Up to approximately 30 months or 2.5 years
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
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CONTACT
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University of California (UC) Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGStanford Medicine Cancer Center
Stanford, California, United States
RECRUITINGAdvent Health
Orlando, Florida, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGThe University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
RECRUITINGIndiana University (IU) Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITING...and 72 more locations