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NCT02952534 · OUTCOME

Steady State Trough (Cmin) Level Rucaparib Concentrations

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency · Source last updated 2023-06-09

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

Measure
MEDIAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113

What was measured

Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.

Analysis population: Safety population with at least one PK sample collected. The safety population consists of all patients who received at least 1 dose of protocol-specified treatment.

Groups in this outcome

BRCA Mutation

Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.

ATM Mutation

Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.

CDK12 Mutation

Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.

CHEK2 Mutation

Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.

Other Gene Mutation

Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.

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

Analysis denominator · Participants

GroupSource count
BRCA Mutation101
ATM Mutation51
CDK12 Mutation14
CHEK2 Mutation5
Other Gene Mutation13

Reported measurements

Day 29

Analysis denominator · Participants

GroupSource count
BRCA Mutation101
ATM Mutation48
CDK12 Mutation14
CHEK2 Mutation5
Other Gene Mutation13
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BRCA Mutation1539.565966.2604Not reportedNot reportedNot reported
ATM Mutation1605.002856.2478Not reportedNot reportedNot reported
CDK12 Mutation1639.3571428.5691Not reportedNot reportedNot reported
CHEK2 Mutation1286.9981138.2119Not reportedNot reportedNot reported
Other Gene Mutation1189.845748.3045Not reportedNot reportedNot reported
Day 57

Analysis denominator · Participants

GroupSource count
BRCA Mutation85
ATM Mutation38
CDK12 Mutation12
CHEK2 Mutation3
Other Gene Mutation11
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BRCA Mutation1578.3531057.8049Not reportedNot reportedNot reported
ATM Mutation1600.3801198.3899Not reportedNot reportedNot reported
CDK12 Mutation1405.167806.4642Not reportedNot reportedNot reported
CHEK2 Mutation1841.6672106.3362Not reportedNot reportedNot reported
Other Gene Mutation1792.4991672.7732Not reportedNot reportedNot reported
Day 85

Analysis denominator · Participants

GroupSource count
BRCA Mutation71
ATM Mutation30
CDK12 Mutation10
CHEK2 Mutation2
Other Gene Mutation9
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BRCA Mutation1308.704693.6717Not reportedNot reportedNot reported
ATM Mutation1505.400802.0812Not reportedNot reportedNot reported
CDK12 Mutation1699.700991.9922Not reportedNot reportedNot reported
CHEK2 Mutation815.500557.9073Not reportedNot reportedNot reported
Other Gene Mutation2255.8891831.9626Not reportedNot reportedNot reported
Day 113

Analysis denominator · Participants

GroupSource count
BRCA Mutation60
ATM Mutation22
CDK12 Mutation10
CHEK2 Mutation2
Other Gene Mutation8
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
BRCA Mutation1533.690889.6130Not reportedNot reportedNot reported
ATM Mutation1515.3001291.8497Not reportedNot reportedNot reported
CDK12 Mutation1520.700884.1374Not reportedNot reportedNot reported
CHEK2 Mutation728.000469.5189Not reportedNot reportedNot reported
Other Gene Mutation1433.875637.4535Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        966.2604
        value
        1539.565
      2. group Id
        OG001
        spread
        856.2478
        value
        1605.002
      3. group Id
        OG002
        spread
        1428.5691
        value
        1639.357
      4. group Id
        OG003
        spread
        1138.2119
        value
        1286.998
      5. group Id
        OG004
        spread
        748.3045
        value
        1189.845
    denoms
    1. counts
      1. group Id
        OG000
        value
        101
      2. group Id
        OG001
        value
        48
      3. group Id
        OG002
        value
        14
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        13
      units
      Participants
    title
    Day 29
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1057.8049
        value
        1578.353
      2. group Id
        OG001
        spread
        1198.3899
        value
        1600.380
      3. group Id
        OG002
        spread
        806.4642
        value
        1405.167
      4. group Id
        OG003
        spread
        2106.3362
        value
        1841.667
      5. group Id
        OG004
        spread
        1672.7732
        value
        1792.499
    denoms
    1. counts
      1. group Id
        OG000
        value
        85
      2. group Id
        OG001
        value
        38
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        11
      units
      Participants
    title
    Day 57
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        693.6717
        value
        1308.704
      2. group Id
        OG001
        spread
        802.0812
        value
        1505.400
      3. group Id
        OG002
        spread
        991.9922
        value
        1699.700
      4. group Id
        OG003
        spread
        557.9073
        value
        815.500
      5. group Id
        OG004
        spread
        1831.9626
        value
        2255.889
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        9
      units
      Participants
    title
    Day 85
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        889.6130
        value
        1533.690
      2. group Id
        OG001
        spread
        1291.8497
        value
        1515.300
      3. group Id
        OG002
        spread
        884.1374
        value
        1520.700
      4. group Id
        OG003
        spread
        469.5189
        value
        728.000
      5. group Id
        OG004
        spread
        637.4535
        value
        1433.875
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        8
      units
      Participants
    title
    Day 113
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      51
    3. group Id
      OG002
      value
      14
    4. group Id
      OG003
      value
      5
    5. group Id
      OG004
      value
      13
    units
    Participants
description
Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.
dispersion Type
Standard Deviation
groups
  1. description
    Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
    id
    OG000
    title
    BRCA Mutation
  2. description
    Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
    id
    OG001
    title
    ATM Mutation
  3. description
    Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
    id
    OG002
    title
    CDK12 Mutation
  4. description
    Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
    id
    OG003
    title
    CHEK2 Mutation
  5. description
    Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
    id
    OG004
    title
    Other Gene Mutation
param Type
MEDIAN
population Description
Safety population with at least one PK sample collected. The safety population consists of all patients who received at least 1 dose of protocol-specified treatment.
reporting Status
POSTED
time Frame
Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113
title
Steady State Trough (Cmin) Level Rucaparib Concentrations
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice