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A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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

NCT02608125•Principia Biopharma, a Sanofi Company

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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).

Locations (12)

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

Key Dates

Start Date

October 28, 2015

Primary Completion Date

June 23, 2020

Completion Date

June 23, 2020

Last Updated

December 24, 2020

Enrollment

ACTUAL participants

Conditions

Solid TumorsMetastatic Urothelial Carcinoma & Renal Pelvis & Ureter

Interventions

PRN1371

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGNA

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

NCT06658951

HER2-positive Advanced Malignant Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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