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NCT00628251 · OUTCOME

Objective Response Rate (ORR)

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

What was measured

ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.

Groups in this outcome

Olaparib 200 mg bd

Olaparib (AZD2281) 200 mg oral capsules twice daily

Olaparib 400 mg bd

Olaparib (AZD2281) 400 mg oral capsules twice daily

Liposomal Doxorubicin

Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks

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 200 mg bd32
Olaparib 400 mg bd32
Liposomal Doxorubicin33

Reported measurements

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd0Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd0Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin0Not reportedNot reportedNot reportedNot reported
Number of Partial responders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd8Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd10Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.32
    estimate Comment
    An odds ratio \>1 favoured olaparib
    group Description
    Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1291
    p Value Comment
    2-sided p-value
    param Type
    Odds Ratio (OR)
    param Value
    2.27
    statistical Comment
    Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.01
    estimate Comment
    An odds ratio \>1 favoured olaparib.
    group Description
    Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3131
    p Value Comment
    2-sided p-value
    param Type
    Odds Ratio (OR)
    param Value
    1.90
    statistical Comment
    Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.76
    estimate Comment
    An odds ratio \>1 favoured olaparib
    group Description
    Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1079
    param Type
    Odds Ratio (OR)
    param Value
    2.69
    statistical Comment
    The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.32
    estimate Comment
    An odds ratio \>1 favoured olaparib
    group Description
    Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1291
    p Value Comment
    2-sided p-value
    param Type
    Odds Ratio (OR)
    param Value
    2.27
    statistical Comment
    Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.01
    estimate Comment
    An odds ratio \>1 favoured olaparib.
    group Description
    Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3131
    p Value Comment
    2-sided p-value
    param Type
    Odds Ratio (OR)
    param Value
    1.90
    statistical Comment
    Analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    0.81
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    9.76
    estimate Comment
    An odds ratio \>1 favoured olaparib
    group Description
    Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.1079
    param Type
    Odds Ratio (OR)
    param Value
    2.69
    statistical Comment
    The analysis was performed using logistic regression with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        6
    title
    Number of Partial responders
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      33
    units
    Participants
description
ORR was defined according to RECIST. Complete response (CR) or partial response - (PR)- 30% decrease Patients with a best RECIST response of CR or PR had to have a confirmed response at least 28 days later.
groups
  1. description
    Olaparib (AZD2281) 200 mg oral capsules twice daily
    id
    OG000
    title
    Olaparib 200 mg bd
  2. description
    Olaparib (AZD2281) 400 mg oral capsules twice daily
    id
    OG001
    title
    Olaparib 400 mg bd
  3. description
    Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
    id
    OG002
    title
    Liposomal Doxorubicin
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

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