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NCT03207347 · ClinicalTrials.gov registry record · Phase 2

A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)

A Phase 2 study of Renal Cell Carcinoma and Cholangiocarcinoma, sponsored by University of Florida.

Completed
Registry status
Phase 2
Development phase
37
Enrollment target
3
Study locations

NCT03207347: Completed Phase 2 study of Renal Cell Carcinoma and Cholangiocarcinoma, sponsored by University of Florida.

NCT03207347 is a Phase 2 study of Renal Cell Carcinoma and Cholangiocarcinoma that has completed, run by University of Florida. The registered enrollment target is 37 participants, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (85% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03207347, a Phase 2 study of Renal Cell Carcinoma and Cholangiocarcinoma, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 2
Development phase
37 participants
Enrollment target
3
Study locations

Study Summary

This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.

Primary Outcome

Determine the objective response rate (ORR), which is defined as the percentage of subjects achieving a best overall response of partial or complete response (according to RECIST v1.1 criteria) from the start of the treatment until disease progression/recurrence or 30 days after the end of treatment, whichever occurs first. Per RECIST v1.1 criteria, a partial response is defined as a 30% or more decrease in the sum of the largest diameters of the target lesions. Per RECIST v1.1 criteria, a compl

Interventions

  • DRUG Niraparib

Study Locations (3)

Florida

  • University of Florida - Gainesville
  • University of Miami - Miami
  • Orlando Health UF Health Cancer Center - Orlando

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2018-08-13
Est. Completion 2022-08-30
Phase Phase 2
University of Florida

1,106 total trials

What the finished NCT03207347 record still lists

NCT03207347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 243-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (85% lower).

The record links to 4 conditions, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Niraparib is the first listed.

NCT03207347 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT03207347 about?

NCT03207347 is a clinical study titled "A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001)". This open-label, non-randomized study will investigate the use of niraparib in patients with tumors known to have mutations in BAP1 and other select DNA damage response pathway genes.

What is the current status of trial NCT03207347?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2018-08-13. Estimated completion is 2022-08-30.

What conditions does trial NCT03207347 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma, Cholangiocarcinoma, Mesothelioma, Uveal Melanoma.

What interventions are being tested in trial NCT03207347?

The interventions under investigation include: Niraparib (DRUG).

Who is sponsoring clinical trial NCT03207347?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03207347 being conducted?

This trial has 3 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03207347's enrollment target sits among peer trials

37 88th of 121 higher than 34 of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03207347, the US trial registry maintained by the National Library of Medicine. NCT03207347 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.