NCT05490771 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
- id
- FG000
- title
- Treatment (Copanlisib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 18
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Other complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Still on treatment
- reasons
- group Id
- FG000
- num Subjects
- 5
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Ineligible
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 31
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 30
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 28
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 30
- type
- Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The PIK3CA mutations status was determined by a CLIA-approved assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed for 30 patients based on confirmation report as of August 1, 2019.
- recruitment Details
- Subprotocol Z1F was activated on June 20, 2018. Thirty-five patients were enrolled between June 2018 and December 2018.
Complete source fields
- groups
- description
- Patients receive copanlisib IV over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
- id
- FG000
- title
- Treatment (Copanlisib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 18
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Other complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Still on treatment
- reasons
- group Id
- FG000
- num Subjects
- 5
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Ineligible
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 31
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 30
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 28
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 30
- type
- Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 25
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The PIK3CA mutations status was determined by a CLIA-approved assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed for 30 patients based on confirmation report as of August 1, 2019.
- recruitment Details
- Subprotocol Z1F was activated on June 20, 2018. Thirty-five patients were enrolled between June 2018 and December 2018.
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Preserved source evidence · Not medical advice
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