NCT03654833 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Rucaparib in DNA damage sensitive relapsed mesothelioma. 600mg twice daily (BID) every 28 days. Tablet. Oral use.
- id
- FG000
- title
- MiST-1
- description
- Abemaciclib in p16INK4A negative mesothelioma. 200mg twice daily (BID) for 28 days. Capsule. Oral use.
- id
- FG001
- title
- MiST-2
- description
- Pembrolizumab and bemcentinib in relapsed mesothelioma. Bemcentinib will be administered once daily. On first 3 days of administration the dose will be a loading of 400mg. From Day 4 onwards, patients will receive a daily dose of 200mg. Each cycle will be 21 days. Pembrolizumab will be given at a fixed dose of 200mg via IV infusion on Day 1 of each 21-day cycle. Each drug will be administered for up to 35 cycles or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression. Injection, Capsule. Intravenous use, Oral use.
- id
- FG002
- title
- MiST-3
- description
- Atezolizumab and Bevacizumab in relapsed mesothelioma. Atezolizumab will be given as a fixed dose of 1200mg via IV infusion on day 1 of a 21-day cycle. Bevacizumab will be given as 15 mg/kg via IV infusion on Days 1 of a 21-day cycle. Infusion. Intravenous use.
- id
- FG003
- title
- MiST-4
- description
- Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma. Niraparib will be administered once daily depending on patient's weight and platelet count. A cycle consist of 21 days and there will be up to 35 cycles in total: • ≥77 kg and ≥150,000 μL 300 mg (3 X 100 mg capsules) • \<77 kg or \<150,000 μL 200 mg (2 X 100 mg capsules) Dostarlimab will be given at a fixed dose of 500mg via IV infusion on Day 1 of each 21-day cycle for 4 cycles. Followed by 1000mg via IV infusion on Day 1 of each 42-day cycle for up to 24 months. • Each will be administered for up to 24 months or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression. Capsule, Infusion. Oral use, Intravenous use.
- id
- FG004
- title
- MiST-5
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- group Id
- FG001
- num Subjects
- 26
- group Id
- FG002
- num Subjects
- 26
- group Id
- FG003
- num Subjects
- 26
- group Id
- FG004
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- group Id
- FG001
- num Subjects
- 26
- group Id
- FG002
- num Subjects
- 26
- group Id
- FG003
- num Subjects
- 26
- group Id
- FG004
- num Subjects
- 26
- 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
- type
- NOT COMPLETED
- title
- Baseline
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 5
- group Id
- FG004
- num Subjects
- 5
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Toxicity
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Patient Choice
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Did not attend 12 week CT scan
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- group Id
- FG001
- num Subjects
- 26
- group Id
- FG002
- num Subjects
- 26
- group Id
- FG003
- num Subjects
- 26
- group Id
- FG004
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 14
- group Id
- FG002
- num Subjects
- 18
- group Id
- FG003
- num Subjects
- 18
- group Id
- FG004
- num Subjects
- 21
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 8
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 5
- type
- NOT COMPLETED
- title
- 12 Weeks
- drop Withdraws
- reasons
- 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
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Missed 24 week visit
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Patient Choice
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 6
- type
- Lack of Efficacy
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 14
- group Id
- FG002
- num Subjects
- 18
- group Id
- FG003
- num Subjects
- 18
- group Id
- FG004
- num Subjects
- 21
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 10
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 11
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 8
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 10
- type
- NOT COMPLETED
- title
- 24 Weeks
- pre Assignment Details
- The MiST Master protocol states "Trial Design of the MiST study is in three stages: Stage 1-molecular pre-screening: The MiST Master protocol describes the identification of patients, biomarker testing and analysis. Stage 2- Treatment: The MiST treatment protocol will be specific to the treatment allocated to the patient Stage 3-Genomic Profiling": The Screening target for the pre-screening stage was 186 patients. After screening the number recruited for the treatment stage was 130 patients.
Complete source fields
- groups
- description
- Rucaparib in DNA damage sensitive relapsed mesothelioma. 600mg twice daily (BID) every 28 days. Tablet. Oral use.
- id
- FG000
- title
- MiST-1
- description
- Abemaciclib in p16INK4A negative mesothelioma. 200mg twice daily (BID) for 28 days. Capsule. Oral use.
- id
- FG001
- title
- MiST-2
- description
- Pembrolizumab and bemcentinib in relapsed mesothelioma. Bemcentinib will be administered once daily. On first 3 days of administration the dose will be a loading of 400mg. From Day 4 onwards, patients will receive a daily dose of 200mg. Each cycle will be 21 days. Pembrolizumab will be given at a fixed dose of 200mg via IV infusion on Day 1 of each 21-day cycle. Each drug will be administered for up to 35 cycles or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression. Injection, Capsule. Intravenous use, Oral use.
- id
- FG002
- title
- MiST-3
- description
- Atezolizumab and Bevacizumab in relapsed mesothelioma. Atezolizumab will be given as a fixed dose of 1200mg via IV infusion on day 1 of a 21-day cycle. Bevacizumab will be given as 15 mg/kg via IV infusion on Days 1 of a 21-day cycle. Infusion. Intravenous use.
- id
- FG003
- title
- MiST-4
- description
- Dostarlimab and Niraparib in Patients with Platinum Sensitive Relapsed Mesothelioma. Niraparib will be administered once daily depending on patient's weight and platelet count. A cycle consist of 21 days and there will be up to 35 cycles in total: • ≥77 kg and ≥150,000 μL 300 mg (3 X 100 mg capsules) • \<77 kg or \<150,000 μL 200 mg (2 X 100 mg capsules) Dostarlimab will be given at a fixed dose of 500mg via IV infusion on Day 1 of each 21-day cycle for 4 cycles. Followed by 1000mg via IV infusion on Day 1 of each 42-day cycle for up to 24 months. • Each will be administered for up to 24 months or until loss of clinical benefit, unacceptable toxicity or symptomatic deterioration attributed to disease progression. Capsule, Infusion. Oral use, Intravenous use.
- id
- FG004
- title
- MiST-5
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- group Id
- FG001
- num Subjects
- 26
- group Id
- FG002
- num Subjects
- 26
- group Id
- FG003
- num Subjects
- 26
- group Id
- FG004
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 26
- group Id
- FG001
- num Subjects
- 26
- group Id
- FG002
- num Subjects
- 26
- group Id
- FG003
- num Subjects
- 26
- group Id
- FG004
- num Subjects
- 26
- 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
- type
- NOT COMPLETED
- title
- Baseline
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 3
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 5
- group Id
- FG004
- num Subjects
- 5
- type
- Lack of Efficacy
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Toxicity
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Patient Choice
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Did not attend 12 week CT scan
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 26
- group Id
- FG001
- num Subjects
- 26
- group Id
- FG002
- num Subjects
- 26
- group Id
- FG003
- num Subjects
- 26
- group Id
- FG004
- num Subjects
- 26
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 14
- group Id
- FG002
- num Subjects
- 18
- group Id
- FG003
- num Subjects
- 18
- group Id
- FG004
- num Subjects
- 21
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 8
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 5
- type
- NOT COMPLETED
- title
- 12 Weeks
- drop Withdraws
- reasons
- 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
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Missed 24 week visit
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- type
- Patient Choice
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 4
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 8
- group Id
- FG004
- num Subjects
- 6
- type
- Lack of Efficacy
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 14
- group Id
- FG002
- num Subjects
- 18
- group Id
- FG003
- num Subjects
- 18
- group Id
- FG004
- num Subjects
- 21
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 10
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 10
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 11
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 8
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 10
- type
- NOT COMPLETED
- title
- 24 Weeks
- pre Assignment Details
- The MiST Master protocol states "Trial Design of the MiST study is in three stages: Stage 1-molecular pre-screening: The MiST Master protocol describes the identification of patients, biomarker testing and analysis. Stage 2- Treatment: The MiST treatment protocol will be specific to the treatment allocated to the patient Stage 3-Genomic Profiling": The Screening target for the pre-screening stage was 186 patients. After screening the number recruited for the treatment stage was 130 patients.
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Preserved source evidence · Independent clinical review pending · Not medical advice
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