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Brief Title: 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

INTRODUCTION

  • Org Study ID: PRN1371-001
  • Secondary ID: N/A
  • NTC ID: NCT02608125
  • Sponsor: Principia Biopharma Inc.

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 is 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 study is a dose escalation study. 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) will be enrolled in patients
with metastatic urothelial carcinoma with fibroblast growth factor receptor (FGFR) 1, 2, 3 or
4 genetic alterations.


  • Overall Status
    Recruiting
  • Start Date
    October 28, 2015
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of treatment related Grade 3 and/or Grade 4 adverse events, defined as dose limiting toxicities, for the doses of PRN1371

Primary Outcome 1 - Timeframe: 28 days on average

CONDITION

  • Solid Tumors
  • Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter

ELIGIBILITY


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).

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Dolca Thomas, MD

Role: Study Director

Affiliation: Principia Biopharma

Overall Contact

Name: Dolca Thomas, MD

Phone: +16504167777

Email: clinicaltrials@principiabio.com

LOCATION

Facility Status Contact
Facility: Johns Hopkins Medicine
Baltimore, Maryland 21205
United States
Status: Recruiting Contact:
Noah Hahn, MD

nhahn4@jhmi.edu
Facility: Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina 27157
United States
Status: Recruiting Contact:
Rhonda Biting, MD

rbiting@wakehealth.edu
Facility: Tennessee Oncology, Sarah Canon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:
Todd Bauer

tbauer@tnonc.com
Facility: Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital
Barcelona, 08035
Spain
Status: Recruiting Contact:
Elena Garralda, MD

Facility: Hospital General Universitario de Elche
Elche, 03203
Spain
Status: Recruiting Contact:
Federico Vazquez Mazon

Facility: Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Status: Recruiting Contact:
Pablo Gajate Borau

Facility: START Madrid-FJD Fundacion Jiminez Diaz
Madrid, 28040
Spain
Status: Recruiting Contact:
Victor Moreno, MD
+34 91 5504800
Facility: Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Status: Recruiting Contact:
Daniel Ernesto Castellano

Facility: START Madrid-CIOCC, Centro Integral Oncológico Clara Campal
Madrid, 28050
Spain
Status: Recruiting Contact:
Valentina Boni, MD
+34 91 7567825
Valentina.Boni@startmadrid.com
Facility: Hospital Virgen del Rocio
Seville, 41013
Spain
Status: Recruiting Contact:
Begona Perez Valderrama