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NCT04171700 · OUTCOME

Progression-free Survival

A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes · Source last updated 2023-10-02

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

Measure
MEDIAN
Unit
month
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study drug until disease progression (up to approximately 2 years)

What was measured

Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.

Analysis population: Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.

Groups in this outcome

Rucaparib Cohort A

Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.

Rucaparib Cohort B

Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.

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

Analysis denominator · Participants

GroupSource count
Rucaparib Cohort A63
Rucaparib Cohort B20

Reported measurements

Source class 1
Values in month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rucaparib Cohort A3.7Not reported1.95.4Not reported
Rucaparib Cohort B3.6Not reported1.66.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        5.4
        value
        3.7
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        6.3
        value
        3.6
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Measure of clinical benefit, defined as the duration from study enrollment to objective tumor progression. Progression was defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (and an absolute increase of at least 5 mm), or unequivocal progression of existing non-target lesions, or the appearance of new lesions. For mCRPC disease, the PCWG3 confirmed bone disease progression criteria (2+2) were also incorporated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with a deleterious mutation in one of the following genes: BRCA1, BRCA2, PALB2, RAD51C, or RAD51D.
    id
    OG000
    title
    Rucaparib Cohort A
  2. description
    Participants with a deleterious mutation in one of the following genes: BARD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
    id
    OG001
    title
    Rucaparib Cohort B
param Type
MEDIAN
population Description
Safety Population - all enrolled participants who received at least 1 dose of protocol-specified treatment.
reporting Status
POSTED
time Frame
From first dose of study drug until disease progression (up to approximately 2 years)
title
Progression-free Survival
type
SECONDARY
unit Of Measure
month

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

Preserved source evidence · Not medical advice