NCT06400238 · 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 60 mg IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Copanlisib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Started Protocol Therapy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 27
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 29
- comment
- Primary efficacy analysis set
- 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 PTEN mutation status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Thirty-one out of the 35 outside lab patients had their samples centrally confirmed.
- recruitment Details
- Subprotocol Z1H was activated on June 20, 2018. Thirty-five patients were enrolled between October 2018 and January 2020. All patients were enrolled through the outside laboratory.
Complete source fields
- groups
- description
- Patients receive copanlisib 60 mg IV over 60 minutes on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Copanlisib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Started Protocol Therapy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 27
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 29
- comment
- Primary efficacy analysis set
- 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 PTEN mutation status was determined by a CLIA-approved assay performed in NCI-MATCH approved laboratory for all patients in this arm. Thirty-one out of the 35 outside lab patients had their samples centrally confirmed.
- recruitment Details
- Subprotocol Z1H was activated on June 20, 2018. Thirty-five patients were enrolled between October 2018 and January 2020. All patients were enrolled through the outside laboratory.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle