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NCT03660826 · OUTCOME

Incidence of Adverse Events

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy up to 50 months.

What was measured

The number of patients who reported at least a grade 3 adverse event were assessed in those who initiated treatment.

Analysis population: Patients who initiated assigned treatment.

Groups in this outcome

Arm I (Cediranib maleate_Group1)

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_Group2)

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_Group1)39
Arm II (Olaparib)40
Arm III (Cediranib Maleate, Olaparib)39
Arm IV (Olaparib, Capivasertib)42
Arm V (Olaparib, Durvalumab)42
Arm VI (Cediranib Maleate, Durvalumab)42
Arm VII (Cediranib maleate_Group2)37

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Cediranib maleate_Group1)28Not reportedNot reportedNot reportedNot reported
Arm II (Olaparib)19Not reportedNot reportedNot reportedNot reported
Arm III (Cediranib Maleate, Olaparib)31Not reportedNot reportedNot reportedNot reported
Arm IV (Olaparib, Capivasertib)24Not reportedNot reportedNot reportedNot reported
Arm V (Olaparib, Durvalumab)21Not reportedNot reportedNot reportedNot reported
Arm VI (Cediranib Maleate, Durvalumab)31Not reportedNot reportedNot reportedNot reported
Arm VII (Cediranib maleate_Group2)28Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        31
      4. group Id
        OG003
        value
        24
      5. group Id
        OG004
        value
        21
      6. group Id
        OG005
        value
        31
      7. group Id
        OG006
        value
        28
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      40
    3. group Id
      OG002
      value
      39
    4. group Id
      OG003
      value
      42
    5. group Id
      OG004
      value
      42
    6. group Id
      OG005
      value
      42
    7. group Id
      OG006
      value
      37
    units
    Participants
description
The number of patients who reported at least a grade 3 adverse event were assessed in those who initiated treatment.
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_Group1)
  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_Group2)
param Type
COUNT_OF_PARTICIPANTS
population Description
Patients who initiated assigned treatment.
reporting Status
POSTED
time Frame
Toxicity was assessed every other week for the first 8 weeks of study therapy and every 8 weeks after the completion or termination of study therapy up to 50 months.
title
Incidence of Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice