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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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 to further evaluate safety and tolerability, preliminary activity, PK, and PD in patients with FGFR genetic alterations.

Official 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 FGFR 1, 2, 3, or 4 Genetic Alterations

Details

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 of 20 patients, enriched for solid tumors with fibroblast growth factor receptor (FGFR) 1, 2, 3 or 4 genetic alterations.

Keywords

Solid Tumors FGFR

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 subjects only:

  • The patient's tumor has been evaluated and prospectively identified as having FGFR 1,2, 3, or 4 genetic alterations.

You CAN'T join 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). Patients with brain metastases are eligible, provided they have shown clinical and radiographically stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of PRN1371.

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Cener accepting new patients
    San Francisco, California, 94115, United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston, Texas, 77030, United States
  • Sarah Canon Research Institute accepting new patients
    Nashville, Tennessee, 37203, United States
  • Wake Forest University Health Sciences Medical Center accepting new patients
    Winston-Salem, North Carolina, 27157, United States
  • Johns Hopkins Medicine accepting new patients
    Baltimore, Maryland, 21205, United States
  • Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital accepting new patients
    Barcelona, 08035, Spain
  • START Madrid-FJD Fundacion Jiminez Diaz accepting new patients
    Madrid, 28040, Spain
  • START Madrid-CIOCC, Centro Integral Oncológico Clara Campal accepting new patients
    Madrid, 28050, Spain

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Principia Biopharma, Inc.
ID
NCT02608125
Phase
Phase 1
Lead Scientist
Rahul Aggarwal
Study Type
Interventional
Last Updated
November 21, 2017
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