NCT04439136 · 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 afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
- id
- FG000
- title
- Treatment (Afatinib Dimaleate)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never Started Treatment
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 27
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Alternative Therapy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Increased Tumor Burden
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Symptomatic Detrioration
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 40
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 39
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 37
- comment
- One patient ineligible, 2 patients never started treatment. This is the primary analysis population.
- type
- Eligible and Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 37
- comment
- Excluding two who did not receive afatinib treatment and one who was not assessed for toxicity
- type
- Reported Adverse Events Data
- achievements
- group Id
- FG000
- num Subjects
- 0
- comment
- Treatment continued until disease progression or intolerability.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 40
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol B, patients had to have a qualifying ERBB2 actionable mutation.
- recruitment Details
- Subprotocol B was activated on August 12, 2015. Fifty-nine patients were assigned to Subprotocol B after screening, all from screening cohort. Of the 59 patients, 40 patients were enrolled in arm B between August 2015 and June 2017.
Complete source fields
- groups
- description
- Patients receive afatinib dimaleate 40mg PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Afatinib Dimaleate: Given PO
- id
- FG000
- title
- Treatment (Afatinib Dimaleate)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never Started Treatment
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 27
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Alternative Therapy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Increased Tumor Burden
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Symptomatic Detrioration
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 40
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 39
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 37
- comment
- One patient ineligible, 2 patients never started treatment. This is the primary analysis population.
- type
- Eligible and Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 37
- comment
- Excluding two who did not receive afatinib treatment and one who was not assessed for toxicity
- type
- Reported Adverse Events Data
- achievements
- group Id
- FG000
- num Subjects
- 0
- comment
- Treatment continued until disease progression or intolerability.
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 40
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- To be assigned to a specific MATCH subprotocol, patients needed to submit a tumor biopsy for molecular characterization and those with molecular variants addressed by treatments included in the trial entered corresponding MATCH subprotocol. For the subprotocol B, patients had to have a qualifying ERBB2 actionable mutation.
- recruitment Details
- Subprotocol B was activated on August 12, 2015. Fifty-nine patients were assigned to Subprotocol B after screening, all from screening cohort. Of the 59 patients, 40 patients were enrolled in arm B between August 2015 and June 2017.
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