Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03660826 · OUTCOME

Progression-free Survival

Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone · Source last updated 2026-08-28

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
Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).

What was measured

Progression-free survival is defined as the time from the date of study enrollment to the investigator-determined date of progression or death due to any cause, whichever occurs first. For individuals who are alive and progression-free, the censored time at risk will be defined as the time from the study enrollment date to the date of the patient's last radiographic disease assessment.

Analysis population: All patients randomized (Intent-to-Treat).

Groups in this outcome

Arm I (Cediranib maleate_Reference Group 1)

Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA

Arm II (Olaparib)

Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO

Arm III (Cediranib Maleate, Olaparib)

Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO

Arm IV (Olaparib, Capivasertib)

Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO

Arm V (Olaparib, Durvalumab)

Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO

Arm VI (Cediranib Maleate, Durvalumab)

Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA

Arm VII (Cediranib maleate_Reference Group 2)

Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA

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

Analysis denominator · Participants

GroupSource count
Arm I (Cediranib maleate_Reference Group 1)40
Arm II (Olaparib)40
Arm III (Cediranib Maleate, Olaparib)40
Arm IV (Olaparib, Capivasertib)42
Arm V (Olaparib, Durvalumab)42
Arm VI (Cediranib Maleate, Durvalumab)43
Arm VII (Cediranib maleate_Reference Group 2)41

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Cediranib maleate_Reference Group 1)3.8Not reported3.05.4Not reported
Arm II (Olaparib)2.0Not reported1.84.7Not reported
Arm III (Cediranib Maleate, Olaparib)5.5Not reported3.78.3Not reported
Arm IV (Olaparib, Capivasertib)5.6Not reported2.66.0Not reported
Arm V (Olaparib, Durvalumab)3.7Not reported2.24.9Not reported
Arm VI (Cediranib Maleate, Durvalumab)6.0Not reported3.87.8Not reported
Arm VII (Cediranib maleate_Reference Group 2)4.1Not reported3.07.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Comparing Arm II vs Arm I (reference group)
    p Value
    0.93
    p Value Comment
    Comparing Arm II vs Arm I (reference group)
    param Type
    Hazard Ratio (HR)
    param Value
    1.45
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    group Description
    Comparing Arm III vs Arm I
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.06
    param Type
    Hazard Ratio (HR)
    param Value
    0.7
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.70
    group Description
    Comparing Arm IV vs Arm VII
    group Ids
    1. OG003
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.62
    param Type
    Hazard Ratio (HR)
    param Value
    1.06
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.46
    group Description
    Comparing Arm V vs Arm VII
    group Ids
    1. OG004
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.36
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
    statistical Method
    Log Rank
  5. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.25
    group Description
    Comparing Arm VI vs VII
    group Ids
    1. OG005
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.14
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.91
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Comparing Arm II vs Arm I (reference group)
    p Value
    0.93
    p Value Comment
    Comparing Arm II vs Arm I (reference group)
    param Type
    Hazard Ratio (HR)
    param Value
    1.45
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    group Description
    Comparing Arm III vs Arm I
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.06
    param Type
    Hazard Ratio (HR)
    param Value
    0.7
    statistical Method
    Log Rank
  3. ci Lower Limit
    0.67
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.70
    group Description
    Comparing Arm IV vs Arm VII
    group Ids
    1. OG003
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.62
    param Type
    Hazard Ratio (HR)
    param Value
    1.06
    statistical Method
    Log Rank
  4. ci Lower Limit
    0.58
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.46
    group Description
    Comparing Arm V vs Arm VII
    group Ids
    1. OG004
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.36
    param Type
    Hazard Ratio (HR)
    param Value
    0.92
    statistical Method
    Log Rank
  5. ci Lower Limit
    0.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.25
    group Description
    Comparing Arm VI vs VII
    group Ids
    1. OG005
    2. OG006
    non Inferiority Type
    SUPERIORITY
    p Value
    0.14
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        5.4
        value
        3.8
      2. group Id
        OG001
        lower Limit
        1.8
        upper Limit
        4.7
        value
        2.0
      3. group Id
        OG002
        lower Limit
        3.7
        upper Limit
        8.3
        value
        5.5
      4. group Id
        OG003
        lower Limit
        2.6
        upper Limit
        6.0
        value
        5.6
      5. group Id
        OG004
        lower Limit
        2.2
        upper Limit
        4.9
        value
        3.7
      6. group Id
        OG005
        lower Limit
        3.8
        upper Limit
        7.8
        value
        6.0
      7. group Id
        OG006
        lower Limit
        3.0
        upper Limit
        7.0
        value
        4.1
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      40
    3. group Id
      OG002
      value
      40
    4. group Id
      OG003
      value
      42
    5. group Id
      OG004
      value
      42
    6. group Id
      OG005
      value
      43
    7. group Id
      OG006
      value
      41
    units
    Participants
description
Progression-free survival is defined as the time from the date of study enrollment to the investigator-determined date of progression or death due to any cause, whichever occurs first. For individuals who are alive and progression-free, the censored time at risk will be defined as the time from the study enrollment date to the date of the patient's last radiographic disease assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients randomized to Cedinarib reference arm during the recruitment period (09/04/2018-06/17/2019). Patients receive Cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
    id
    OG000
    title
    Arm I (Cediranib maleate_Reference Group 1)
  2. description
    Patients receive olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
    id
    OG001
    title
    Arm II (Olaparib)
  3. description
    Patients receive olaparib PO BID and cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
    id
    OG002
    title
    Arm III (Cediranib Maleate, Olaparib)
  4. description
    Patients receive olaparib PO BID on days 1-28 and capivasertib PO BID on days 1-4 each week. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Capivasertib: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
    id
    OG003
    title
    Arm IV (Olaparib, Capivasertib)
  5. description
    Patients receive olaparib PO BID on days 1-28 and durvalumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA Olaparib: Given PO
    id
    OG004
    title
    Arm V (Olaparib, Durvalumab)
  6. description
    Patients receive cediranib maleate PO QD on days 1-5 each week and durvalumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Durvalumab: Given IV Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
    id
    OG005
    title
    Arm VI (Cediranib Maleate, Durvalumab)
  7. description
    Patients randomized to Cedinarib reference arm during the recruitment period (08/16/2021-06/28/2023). Patients receive cediranib maleate PO QD. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Additionally, patients undergo blood sample collection, bone marrow aspiration and biopsy, CT, Echo or MUGA on study. Biospecimen Collection: Undergo blood sample collection Bone Marrow Aspirate: Undergo bone marrow aspiration and biopsy Bone Marrow Biopsy: Undergo bone marrow aspiration and biopsy Cediranib: Given PO Cediranib Maleate: Given PO Computed Tomography: Undergo CT scan Echocardiography: Undergo Echo Multigated Acquisition Scan: Undergo MUGA
    id
    OG006
    title
    Arm VII (Cediranib maleate_Reference Group 2)
param Type
MEDIAN
population Description
All patients randomized (Intent-to-Treat).
reporting Status
POSTED
time Frame
Scans were done every 8 weeks for the first year and then every 12 weeks thereafter until disease progression. Vital status was assessed every 3 months for 2 years and then every 6 months for 3 years (5-years total).
title
Progression-free Survival
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice