NCT04439240 · 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 AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
- id
- FG000
- title
- Treatment (AZD4547)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never started treatment
- reasons
- group Id
- FG000
- num Subjects
- 12
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 25
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Other diseases
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Clinical concerns for progression and increasing tumor marker
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Symptomatic decline
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Pogression of the lymphadenopathy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Clinical progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 52
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 50
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 49
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 48
- comment
- 2 patients ineligible, 1 patient never started treatment, 1 patient both ineligible and never started treatment. This is the primary analysis population.
- type
- Eligible and Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 49
- comment
- 1 of the 50 treated patients had no adverse events reported
- 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
- 52
- 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 subprotocol W, patients had to have tumors harboring aberrations in FGFR 1-3.
- recruitment Details
- Subprotocol W was activated on May 31, 2016. 70 patients were assigned to Subprotocol W after screening, all from screening cohort. Of the 70 patients, 52 patients from 47 different sites enrolled in the study between July 2016 and June 2017.
Complete source fields
- groups
- description
- Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. FGFR Inhibitor AZD4547: Given PO
- id
- FG000
- title
- Treatment (AZD4547)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Never started treatment
- reasons
- group Id
- FG000
- num Subjects
- 12
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 25
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Other diseases
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Clinical concerns for progression and increasing tumor marker
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Symptomatic decline
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Pogression of the lymphadenopathy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Clinical progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 52
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 50
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 49
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 48
- comment
- 2 patients ineligible, 1 patient never started treatment, 1 patient both ineligible and never started treatment. This is the primary analysis population.
- type
- Eligible and Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 49
- comment
- 1 of the 50 treated patients had no adverse events reported
- 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
- 52
- 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 subprotocol W, patients had to have tumors harboring aberrations in FGFR 1-3.
- recruitment Details
- Subprotocol W was activated on May 31, 2016. 70 patients were assigned to Subprotocol W after screening, all from screening cohort. Of the 70 patients, 52 patients from 47 different sites enrolled in the study between July 2016 and June 2017.
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