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BRIEF 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

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


  • Org Study ID: PRN1371-001
  • Secondary ID:
  • NCT ID: NCT02608125
  • NCT Alias:
  • Sponsor: Principia Biopharma Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting Start Date: November 2015 Phase 1 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 - Time Frame: 28 days on average

Condition:

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

Eligibility

Criteria:
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).
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Dolca Thomas, MD

Role: Study Director

Affiliation: Principia Biopharma

Overall Contact

Name: Ann Neale, RN BSN

Phone: +16504167784

Email: clinicaltrials@principiabio.com

Locations

Facility Status Contact
UCSF Helen Diller Family Comprehensive Cancer Cener
San Francisco, California 94115
United States
Completed
Johns Hopkins Medicine
Baltimore, Maryland 21205
United States
Recruiting Noah Hahn, MD

nhahn4@jhmi.edu
Wake Forest University Health Sciences Medical Center
Winston-Salem, North Carolina 27157
United States
Active, not recruiting
Tennessee Oncology, Sarah Canon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Todd Bauer

tbauer@tnonc.com
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Active, not recruiting
Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital
Barcelona, 08035
Spain
Active, not recruiting
START Madrid-FJD Fundacion Jiminez Diaz
Madrid, 28040
Spain
Active, not recruiting
START Madrid-CIOCC, Centro Integral Oncológico Clara Campal
Madrid, 28050
Spain
Active, not recruiting