Spots Global Cancer Trial Database for A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
Official Title: A Phase I Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR 1-4 Kinase Inhibitor, in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Cohort in Patients With Metastatic Urothelial Carcinoma With FGFR 1, 2, 3, or 4 Genetic Alterations
Study ID: NCT02608125
Interventions
Study Description
Brief Summary: This is a multi-center, open label, non-randomized Phase 1 study, to be conducted in two parts, Part A, and Part B. Part A in solid tumors included the dose escalation phase for evaluating the safety and tolerability profile of PRN1371, a FGFR 1-4 Kinase inhibitor. Part B is the Cohort Expansion phase in patients with metastatic urothelial carcinoma to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.
Detailed Description: The protocol specifies rules for dose-limiting toxicity and a maximum tolerated dose (MTD). To gain further experience with the MTD, and/or at some lower optimal biologic dose level, an expansion cohort (Part B) enrolled patients with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Helen Diller Family Comprehensive Cancer Cener, San Francisco, California, United States
Johns Hopkins Medicine, Baltimore, Maryland, United States
Wake Forest University Health Sciences Medical Center, Winston-Salem, North Carolina, United States
Tennessee Oncology, Sarah Canon Research Institute, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, Barcelona, , Spain
Hospital General Universitario de Elche, Elche, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
START Madrid-FJD Fundacion Jiminez Diaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Virgen del Rocio, Seville, , Spain
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
