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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:November 2015
End Date:February 2021
Contact:Ann Neale, RN BSN
Email:clinicaltrials@principiabio.com
Phone:+16504167784

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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

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.

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.

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).
We found this trial at
6
sites
Winston-Salem, North Carolina 27103
Principal Investigator: Rhonda Biting, MD
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Winston-Salem, NC
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Baltimore, Maryland 21231
Phone: 410-955-9769
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Baltimore, MD
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Barcelona, 08035
Principal Investigator: Cinta Hierro, MD, PhD
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Barcelona,
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Sarina Piha-Paul, MD
Phone: 713-745-5053
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Nashville, Tennessee 37203
Principal Investigator: Todd Bauer, MD
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Nashville, TN
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1600 Divisadero Street
San Francisco, California 94115
Principal Investigator: Rahul Aggarwal, MD
Phone: 415-514-6955
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San Francisco, CA
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