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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02608125
• Date of registration: 18/09/2015
• Prospective Registration: Yes
• Primary sponsor: Principia Biopharma Inc.
• Public title: A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
• Scientific 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
• Date of first enrolment: October 28, 2015
• Target sample size: 45
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02608125
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Spain, United States

Contacts

• Name: Dolca Thomas, MD
• Affiliation: Principia Biopharma

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Metastatic Urothelial Carcinoma & Renal Pelvis & Ureter

Solid Tumors

Intervention(s)

Drug: PRN1371

Primary Outcome(s)

Incidence of treatment related Grade 3 and/or Grade 4 adverse events, defined as dose limiting toxicities, for the doses of PRN1371 [Time Frame: 28 days on average]

Secondary Outcome(s)

Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on serum FGF23 (Part A only) levels [Time Frame: While being treated with PRN1371 (expected average of 16 weeks)]

Duration of response in patients treated with PRN1371 [Time Frame: Every 8 weeks while being treated with PRN1371 (expected average 16 weeks)]

Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on calcium levels [Time Frame: While being treated with PRN1371 (expected average of 16 weeks)]

Pharmacodynamic profile of PRN1371 including the effect of PRN1371 on phosphate levels [Time Frame: While being treated with PRN1371 (expected average of 16 weeks)]

Objective response rate (ORR) as measured by RECIST v1.1 in patients treated with PRN1371 [Time Frame: Every 8 weeks while being treated with PRN1371 (expected average of 16 weeks)]

Pharmacokinetic profile of PRN1371 including area under the serum concentration-time curve [Time Frame: Days 1 and 15]

Pharmacokinetic profile of PRN1371 including maximum serum concentration [Time Frame: Days 1 and 15]

Pharmacokinetic profile of PRN1371 including time to maximum serum concentration [Time Frame: Days 1 and 15]

Secondary ID(s)

PRN1371-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors