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

NCT02608125 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-12-24

No results posted yet for this study

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 in solid tumors included 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.

Conditions

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

Interventions

DRUG

PRN1371

Sponsors & Collaborators

  • Principia Biopharma, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-28
Primary Completion
2020-06-23
Completion
2020-06-23

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608125 on ClinicalTrials.gov