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NCT01891344 · OUTCOME

Steady State Trough (Cmin) Level Rucaparib Concentrations

A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) · Source last updated 2023-06-12

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks

What was measured

Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available.

Analysis population: All Part 1 and Part 2 patients with at least one PK sample collected

Groups in this outcome

Part 1 Overall

Includes all Part 1 patients

Part 2 Overall

Includes all Part 2 patients

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

Analysis denominator · Participants

GroupSource count
Part 1 Overall196
Part 2 Overall267

Reported measurements

Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Part 1 Overall196
Part 2 Overall267
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1 Overall2020.761145.164Not reportedNot reportedNot reported
Part 2 Overall2276.371587.586Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Part 1 Overall186
Part 2 Overall242
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1 Overall1652.27935.503Not reportedNot reportedNot reported
Part 2 Overall1689.831039.953Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Part 1 Overall159
Part 2 Overall174
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1 Overall1557.32952.903Not reportedNot reportedNot reported
Part 2 Overall1552.091054.346Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Part 1 Overall142
Part 2 Overall149
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1 Overall1530.41765.940Not reportedNot reportedNot reported
Part 2 Overall1629.141026.999Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1145.164
        value
        2020.76
      2. group Id
        OG001
        spread
        1587.586
        value
        2276.37
    denoms
    1. counts
      1. group Id
        OG000
        value
        196
      2. group Id
        OG001
        value
        267
      units
      Participants
    title
    Cycle 1 Day 15
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        935.503
        value
        1652.27
      2. group Id
        OG001
        spread
        1039.953
        value
        1689.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        242
      units
      Participants
    title
    Cycle 2 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        952.903
        value
        1557.32
      2. group Id
        OG001
        spread
        1054.346
        value
        1552.09
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        174
      units
      Participants
    title
    Cycle 3 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        765.940
        value
        1530.41
      2. group Id
        OG001
        spread
        1026.999
        value
        1629.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      2. group Id
        OG001
        value
        149
      units
      Participants
    title
    Cycle 4 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      267
    units
    Participants
description
Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available.
dispersion Type
Standard Deviation
groups
  1. description
    Includes all Part 1 patients
    id
    OG000
    title
    Part 1 Overall
  2. description
    Includes all Part 2 patients
    id
    OG001
    title
    Part 2 Overall
param Type
MEAN
population Description
All Part 1 and Part 2 patients with at least one PK sample collected
reporting Status
POSTED
time Frame
Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks
title
Steady State Trough (Cmin) Level Rucaparib Concentrations
type
SECONDARY
unit Of Measure
ng/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice