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NCT02608125 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma
A Phase 1 study, sponsored by Principia Biopharma, a Sanofi Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT02608125 is a Phase 1 study that was terminated before completion, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 45 participants.
The verdict
NCT02608125, a Phase 1 study, was terminated before completion, sponsored by Principia Biopharma, a Sanofi Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
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.
Interventions
- DRUG PRN1371
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2015-10-28 |
| Est. Completion | 2020-06-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02608125
The ClinicalTrials.gov registry entry for NCT02608125 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Principia Biopharma, a Sanofi Company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PRN1371 is the first listed.
NCT02608125 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02608125 about?
NCT02608125 is a clinical study titled "A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma". 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 pha...
What is the current status of trial NCT02608125?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2015-10-28. Estimated completion is 2020-06-23.
What interventions are being tested in trial NCT02608125?
The interventions under investigation include: PRN1371 (DRUG).
Who is sponsoring clinical trial NCT02608125?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
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