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NCT03397394 · OUTCOME

Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations

Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma · 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
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months

What was measured

Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.

Analysis population: Safety population - all patients who received at least 1 dose of rucaparib and who had at least 1 PK sample collected. The number analyzed at each timepoint includes only those participants who remained on study and with viable samples collected at that timepoint.

Groups in this outcome

HRD Unknown

Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.

HRD Negative

Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.

HRD Positive

Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.

Overall

All 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
HRD Unknown24
HRD Negative13
HRD Positive10
Overall47

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
HRD Unknown24
HRD Negative13
HRD Positive10
Overall47
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HRD Unknown2354.032173.055Not reportedNot reportedNot reported
HRD Negative1927.771352.707Not reportedNot reportedNot reported
HRD Positive1853.841533.622Not reportedNot reportedNot reported
Overall2129.701831.099Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
HRD Unknown10
HRD Negative6
HRD Positive2
Overall18
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HRD Unknown2037.901253.715Not reportedNot reportedNot reported
HRD Negative1331.17357.010Not reportedNot reportedNot reported
HRD Positive643.00688.722Not reportedNot reportedNot reported
Overall1647.331068.270Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
HRD Unknown4
HRD Negative5
HRD Positive2
Overall11
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
HRD Unknown2225.00763.348Not reportedNot reportedNot reported
HRD Negative2058.00705.280Not reportedNot reportedNot reported
HRD Positive1585.00487.904Not reportedNot reportedNot reported
Overall2032.73672.891Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2173.055
        value
        2354.03
      2. group Id
        OG001
        spread
        1352.707
        value
        1927.77
      3. group Id
        OG002
        spread
        1533.622
        value
        1853.84
      4. group Id
        OG003
        spread
        1831.099
        value
        2129.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        47
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1253.715
        value
        2037.90
      2. group Id
        OG001
        spread
        357.010
        value
        1331.17
      3. group Id
        OG002
        spread
        688.722
        value
        643.00
      4. group Id
        OG003
        spread
        1068.270
        value
        1647.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        18
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        763.348
        value
        2225.00
      2. group Id
        OG001
        spread
        705.280
        value
        2058.00
      3. group Id
        OG002
        spread
        487.904
        value
        1585.00
      4. group Id
        OG003
        spread
        672.891
        value
        2032.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        11
      units
      Participants
    title
    Cycle 4 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    2. group Id
      OG001
      value
      13
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      47
    units
    Participants
description
Plasma were collected for trough level PK analysis of rucaparib 1 hour before the morning dose on Cycle 2 Day 1, Cycle 3 Day 1, and Cycle 4 Day 1.
dispersion Type
Standard Deviation
groups
  1. description
    Patients with HRD status unknown who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor genome-wide LOH was not tested or not determined were considered HRD unknown.
    id
    OG000
    title
    HRD Unknown
  2. description
    Patients with HRD status negative who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH \< 10% were considered HRD-negative.
    id
    OG001
    title
    HRD Negative
  3. description
    Patients with HRD status positive who received continuous dosing with rucaparib 600 mg twice a day (BID) in 28-day cycles. Patients whose tumor had genome-wide LOH ≥ 10% were considered HRD-positive.
    id
    OG002
    title
    HRD Positive
  4. description
    All patients
    id
    OG003
    title
    Overall
param Type
MEAN
population Description
Safety population - all patients who received at least 1 dose of rucaparib and who had at least 1 PK sample collected. The number analyzed at each timepoint includes only those participants who remained on study and with viable samples collected at that timepoint.
reporting Status
POSTED
time Frame
From Cycle 2 Day 1 to Cycle 4 Day 1, or approximately 2 months
title
Pharmacokinetics - Trough (Cmin) Level Rucaparib Concentrations
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice