A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma

Stopped early · Phase 1

Conditions studied: Solid Tumors, Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter

In brief

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.

Key facts

Study ID: NCT02608125
Run by: Principia Biopharma, a Sanofi Company
People needed: 45
Starts: 2015-10-28
Expected to finish: 2020-06-23
Last updated by the study team: 2020-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years
Histological or cytological documentation of an advanced solid tumor
Subject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remission
Subject must have evaluable, progressive, and measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, Version 1.1
Adequate bone marrow, liver, and renal function
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
For Part B (expansion) in subjects metastatic urothelial carcinoma:
The patient's tumor has been evaluated and prospectively identified as having FGFR 1, 2, 3, or 4 genetic alterations.

You may not qualify if…

Patients who have received adequate prior treatment with a highly selective FGFR inhibitor
Patients with other major uncontrolled medical conditions, e.g., recent myocardial infarction, stroke, diabetes, active hepatitis
Patients who have received prior systemic anticancer therapy ≤ 3 weeks prior to study start (6 weeks for nitrosourea, antibodies, or mitomycin-C)
Patients diagnosed with another primary malignancy within 3 years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervix
Patients with glioblastoma multiforme
Patient has a primary neoplasm of the brain or known uncontrolled metastases to the central nervous system (CNS).

Where it is running

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

Full record on ClinicalTrials.gov

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