NCT04439149 · 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 PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
- id
- FG000
- title
- Treatment (GSK2636771)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 14
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 23
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 22
- comment
- Primary efficacy analysis set
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 24
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Patients whose tumors harboring PTEN mutation/deletion without loss of PTEN protein expression were assigned to sub-protocol N. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.
- recruitment Details
- Subprotocol N was activated on February 25, 2016. Twenty-four patients were enrolled on EAY131-N between May 5, 2016, and December 5, 2016. All patients were enrolled on the basis of the results from the NCI-MATCH assay.
Complete source fields
- groups
- description
- Patients receive PI3K-beta inhibitor GSK2636771 400mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. PI3K-beta Inhibitor GSK2636771: Given PO
- id
- FG000
- title
- Treatment (GSK2636771)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Never start protocol therapy
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 14
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 23
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 22
- comment
- Primary efficacy analysis set
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 24
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Patients whose tumors harboring PTEN mutation/deletion without loss of PTEN protein expression were assigned to sub-protocol N. The mutation status was determined by MATCH central Oncomine assay for all patients in this arm.
- recruitment Details
- Subprotocol N was activated on February 25, 2016. Twenty-four patients were enrolled on EAY131-N between May 5, 2016, and December 5, 2016. All patients were enrolled on the basis of the results from the NCI-MATCH assay.
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Preserved source evidence · Not medical advice
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