Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03207347 · OUTCOME

Overall Survival

A Trial of Niraparib in BAP1 and Other DNA Damage Response (DDR) Deficient Neoplasms (UF-STO-ETI-001) · Source last updated 2023-09-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
10 months

What was measured

Estimate the median overall survival. Overall survival is defined as the duration of time from date of study entry until date of death or date of last contact.

Groups in this outcome

Cohort A

This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.

Cohort B

This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A23
Cohort B14

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A9.1Not reported2.013.0Not reported
Cohort B7.2Not reported2.915.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        13.0
        value
        9.1
      2. group Id
        OG001
        lower Limit
        2.9
        upper Limit
        15.5
        value
        7.2
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Estimate the median overall survival. Overall survival is defined as the duration of time from date of study entry until date of death or date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    This cohort will enroll patients with mesothelioma, uveal melanoma, renal cell carcinoma (clear cell type), and cholangiocarcinoma. Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
    id
    OG000
    title
    Cohort A
  2. description
    This cohort will enroll patients whose tumors have a known DNA damage response mutation in any of the following genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, BLM, CHEK1, CHEK2, CDK2, CDK4, ERCC, FAM175A, FEN1, IDH1, IDH2, MRE11A, NBN (NBS1), PALB2, POLD1, PRKDC (DNA-PK) PTEN, RAD50, RAD51, RAD52, RAD54, RPA1, SLX4, WRN, or XRCC. This cohort is open to patients with any type of malignancy (except prostate). Niraparib: Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
    id
    OG001
    title
    Cohort B
param Type
MEDIAN
reporting Status
POSTED
time Frame
10 months
title
Overall Survival
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice