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.
| Overal Status | Start Date | Phase | Study Type |
|---|---|---|---|
| Recruiting | Start Date: November 2015 | Phase 1 | Interventional |
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
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
Name: Dolca Thomas, MD
Role: Study Director
Affiliation: Principia Biopharma
Name: Ann Neale, RN BSN
Phone: +16504167784
Email: clinicaltrials@principiabio.com
| 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 |
