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NCT04171700 · OUTCOME

Duration of Response

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 time from initial tumor response to documented tumor progression.

Analysis population: Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).

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: BRD1, 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 A9
Rucaparib Cohort B2

Reported measurements

Source class 1
Values in month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rucaparib Cohort A4.1Not reported3.1NAInsufficient number of participants with events.
Rucaparib Cohort B6.8Not reported2.610.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        3.1
        upper Limit
        NA
        value
        4.1
      2. group Id
        OG001
        lower Limit
        2.6
        upper Limit
        10.9
        value
        6.8
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression.
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: BRD1, BRIP1, FANCA, NBN, RAD51, or RAD51B.
    id
    OG001
    title
    Rucaparib Cohort B
param Type
MEDIAN
population Description
Efficacy population - all participants evaluable for response by RECIST v1.1 (or modified RECIST v1.1/PCWG3 for mCRPC participants).
reporting Status
POSTED
time Frame
From first dose of study drug until disease progression (up to approximately 2 years)
title
Duration of Response
type
SECONDARY
unit Of Measure
month

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

Preserved source evidence · Not medical advice