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NCT01874353 · OUTCOME

To Determine the Exposure to Olaparib by Pharmacokinetic Analysis

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy · Source last updated 2026-07-29

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

Measure
GEOMETRIC_MEAN
Unit
mcg/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO.

What was measured

To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy

Analysis population: Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data. The PK Analysis Set is a subset of the Global FAS; PK analysis was not performed in the China Cohort.

Groups in this outcome

Olaparib 300mg Tablets

Taken orally twice daily

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

Analysis denominator · Participants

GroupSource count
Olaparib 300mg Tablets93

Reported measurements

Day 1 - Pre-dose
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Olaparib 300mg TabletsNANANot reportedNot reportedPrior to receiving olaparib so not calculated
Day 1 - 1 hour
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets3.26312.2Not reportedNot reportedNot reported
Day 15 - Pre-dose
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets0.9295.5Not reportedNot reportedNot reported
Day 15 - 1 hour
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets5.1261.8Not reportedNot reportedNot reported
Day 29 - Pre-dose
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets0.94179.0Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Prior to receiving olaparib so not calculated
        group Id
        OG000
        spread
        NA
        value
        NA
    title
    Day 1 - Pre-dose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        312.2
        value
        3.26
    title
    Day 1 - 1 hour
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        95.5
        value
        0.92
    title
    Day 15 - Pre-dose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        61.8
        value
        5.12
    title
    Day 15 - 1 hour
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        179.0
        value
        0.94
    title
    Day 29 - Pre-dose
denoms
  1. counts
    1. group Id
      OG000
      value
      93
    units
    Participants
description
To determine the exposure to olaparib in patients receiving olaparib maintenance monotherapy
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Taken orally twice daily
    id
    OG000
    title
    Olaparib 300mg Tablets
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) Analysis Set - all patients who receive study treatment as per protocol, do not violate or deviate from the protocol in ways that would significantly affect the PK analyses and have valid PK data. The PK Analysis Set is a subset of the Global FAS; PK analysis was not performed in the China Cohort.
reporting Status
POSTED
time Frame
Pharmacokinetics sampling to be performed in a subset of patients. Sampling times: Day 1 pre-dose & 1 hour; Day 15 pre-dose & 1 hour; Day 29 pre-dose. Assessed until 19 Sep 2016 DCO.
title
To Determine the Exposure to Olaparib by Pharmacokinetic Analysis
type
SECONDARY
unit Of Measure
mcg/mL

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

Preserved source evidence · Not medical advice