NCT03660826 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- 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
- FG000
- title
- Arm I (Cediranib maleate_Reference Group 1)
- 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
- FG001
- title
- Arm II (Olaparib)
- 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
- FG002
- title
- Arm III (Cediranib Maleate, Olaparib)
- 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
- FG003
- title
- Arm IV (Olaparib, Capivasertib)
- 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
- FG004
- title
- Arm V (Olaparib, Durvalumab)
- 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
- FG005
- title
- Arm VI (Cediranib Maleate, Durvalumab)
- 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 MUG
- id
- FG006
- title
- Arm VII (Cediranib maleate_Reference Group 2)
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 40
- group Id
- FG001
- num Subjects
- 40
- group Id
- FG002
- num Subjects
- 40
- group Id
- FG003
- num Subjects
- 42
- group Id
- FG004
- num Subjects
- 42
- group Id
- FG005
- num Subjects
- 43
- group Id
- FG006
- num Subjects
- 41
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 40
- group Id
- FG001
- num Subjects
- 40
- group Id
- FG002
- num Subjects
- 40
- group Id
- FG003
- num Subjects
- 42
- group Id
- FG004
- num Subjects
- 42
- group Id
- FG005
- num Subjects
- 43
- group Id
- FG006
- num Subjects
- 41
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- Trial first activated on 09/04/2018 with reporting groups 1-3. It closed to accrual for reporting groups 1-3 on 06/17/2019. It reopened to accrual for reporting groups 4-7 on 08/16/2021. It closed to accrual for reporting groups 4-7 on 06/28/2023.
Complete source fields
- groups
- 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
- FG000
- title
- Arm I (Cediranib maleate_Reference Group 1)
- 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
- FG001
- title
- Arm II (Olaparib)
- 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
- FG002
- title
- Arm III (Cediranib Maleate, Olaparib)
- 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
- FG003
- title
- Arm IV (Olaparib, Capivasertib)
- 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
- FG004
- title
- Arm V (Olaparib, Durvalumab)
- 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
- FG005
- title
- Arm VI (Cediranib Maleate, Durvalumab)
- 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 MUG
- id
- FG006
- title
- Arm VII (Cediranib maleate_Reference Group 2)
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 40
- group Id
- FG001
- num Subjects
- 40
- group Id
- FG002
- num Subjects
- 40
- group Id
- FG003
- num Subjects
- 42
- group Id
- FG004
- num Subjects
- 42
- group Id
- FG005
- num Subjects
- 43
- group Id
- FG006
- num Subjects
- 41
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 40
- group Id
- FG001
- num Subjects
- 40
- group Id
- FG002
- num Subjects
- 40
- group Id
- FG003
- num Subjects
- 42
- group Id
- FG004
- num Subjects
- 42
- group Id
- FG005
- num Subjects
- 43
- group Id
- FG006
- num Subjects
- 41
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- recruitment Details
- Trial first activated on 09/04/2018 with reporting groups 1-3. It closed to accrual for reporting groups 1-3 on 06/17/2019. It reopened to accrual for reporting groups 4-7 on 08/16/2021. It closed to accrual for reporting groups 4-7 on 06/28/2023.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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