NCT06308822 · 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 erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
- id
- FG000
- title
- Treatment (Erdafitinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 17
- type
- Mutation Status Not Confirmed
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 5
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 34
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 34
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 18
- comment
- Primary efficacy analysis population
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- comment
- Treatment continued until disease progression or intolerability
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The FGFR amplification status was determined by assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed by central MATCH assay for 18 patients.
- recruitment Details
- The study was activated on June 20, 2018. Thirty-five patients were enrolled between August 20, 2018, and April 30, 2019.
Complete source fields
- groups
- description
- Patients receive erdafitinib 8 mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout study. Patients may also undergo blood sample collection and tumor biopsy throughout the trial.
- id
- FG000
- title
- Treatment (Erdafitinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 17
- type
- Mutation Status Not Confirmed
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 5
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 34
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 34
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- Eligible and Treated
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 18
- comment
- Primary efficacy analysis population
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- comment
- Treatment continued until disease progression or intolerability
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The FGFR amplification status was determined by assay performed in a NCI-MATCH approved laboratory for all patients in this arm. Mutation status was confirmed by central MATCH assay for 18 patients.
- recruitment Details
- The study was activated on June 20, 2018. Thirty-five patients were enrolled between August 20, 2018, and April 30, 2019.
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