Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02470585 · OUTCOME

Overall Survival (OS) in the Homologous Recombination Deficiency Population

Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2024-10-26

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the time of randomization to the end of the study, up to 98 months

What was measured

OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.

Analysis population: All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score

Groups in this outcome

Placebo + Carboplatin + Paclitaxel -> Placebo

Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.

Veliparib + Carboplatin + Paclitaxel -> Placebo

Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.

Veliparib + Carboplatin + Paclitaxel -> Veliparib

Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.

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

Analysis denominator · Participants

GroupSource count
Placebo + Carboplatin + Paclitaxel -> Placebo207
Veliparib + Carboplatin + Paclitaxel -> Placebo206
Veliparib + Carboplatin + Paclitaxel -> Veliparib214

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + Carboplatin + Paclitaxel -> Placebo71.5Not reported59.687.6Not reported
Veliparib + Carboplatin + Paclitaxel -> Placebo74.4Not reported65.4NACould not be estimated due to the low number of events
Veliparib + Carboplatin + Paclitaxel -> VeliparibNANot reported73.8NACould not be estimated due to the low number of events

Source statistical analyses

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

  1. ci Lower Limit
    0.640
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.114
    estimate Comment
    Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    group Description
    Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.116
    p Value Comment
    Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
    param Type
    Hazard Ratio (HR)
    param Value
    0.844
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.726
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.242
    estimate Comment
    Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    group Description
    Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.352
    p Value Comment
    Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
    param Type
    Hazard Ratio (HR)
    param Value
    0.949
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.640
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.114
    estimate Comment
    Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    group Description
    Veliparib + Carboplatin + Paclitaxel -\> Veliparib (Arm 3) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.116
    p Value Comment
    Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
    param Type
    Hazard Ratio (HR)
    param Value
    0.844
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.726
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.242
    estimate Comment
    Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    group Description
    Veliparib + Carboplatin + Paclitaxel -\> Placebo (Arm 2) versus Placebo + Carboplatin + Paclitaxel -\> Placebo (Arm 1)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.352
    p Value Comment
    Stratified by residual disease (no residual disease after primary surgery versus any residual disease after primary surgery or interval surgery) and stage of disease (stage III versus stage IV)
    param Type
    Hazard Ratio (HR)
    param Value
    0.949
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.6
        upper Limit
        87.6
        value
        71.5
      2. comment
        Could not be estimated due to the low number of events
        group Id
        OG001
        lower Limit
        65.4
        upper Limit
        NA
        value
        74.4
      3. comment
        Could not be estimated due to the low number of events
        group Id
        OG002
        lower Limit
        73.8
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      207
    2. group Id
      OG001
      value
      206
    3. group Id
      OG002
      value
      214
    units
    Participants
description
OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
    id
    OG000
    title
    Placebo + Carboplatin + Paclitaxel -> Placebo
  2. description
    Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
    id
    OG001
    title
    Veliparib + Carboplatin + Paclitaxel -> Placebo
  3. description
    Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    id
    OG002
    title
    Veliparib + Carboplatin + Paclitaxel -> Veliparib
param Type
MEDIAN
population Description
All randomized participants considered BRCA-Deficient and those determined to have HRD tumors based on HRD score
reporting Status
POSTED
time Frame
From the time of randomization to the end of the study, up to 98 months
title
Overall Survival (OS) in the Homologous Recombination Deficiency Population
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice