NCT04439279 · 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 trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Subprotocol R
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 7
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 17
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Treatment still ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- Eligible
- achievements
- comment
- Adverse event was not assessed on one patient before discontinuing therapy due to withdraw/refusal
- group Id
- FG000
- num Subjects
- 34
- type
- Reported Adverse Events Data
- achievements
- comment
- Treatment continued until disease progression or intolerability.
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 35
- 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 R, patients had to have BRAF fusion or Non-V600E, Non-V600K mutations.
- recruitment Details
- Subprotocol R was activated on August 12, 2015. A total of 50 patients were assigned to this arm after screening, 48 from screening cohort and 2 from outside assay. Of the 50 patients, 35 patients were enrolled to arm R between December 4, 2015 and August 17, 2017.
Complete source fields
- groups
- description
- Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Subprotocol R
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 7
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 17
- type
- Disease progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Complicating disease
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Treatment still ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 35
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 33
- type
- Eligible
- achievements
- comment
- Adverse event was not assessed on one patient before discontinuing therapy due to withdraw/refusal
- group Id
- FG000
- num Subjects
- 34
- type
- Reported Adverse Events Data
- achievements
- comment
- Treatment continued until disease progression or intolerability.
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 35
- 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 R, patients had to have BRAF fusion or Non-V600E, Non-V600K mutations.
- recruitment Details
- Subprotocol R was activated on August 12, 2015. A total of 50 patients were assigned to this arm after screening, 48 from screening cohort and 2 from outside assay. Of the 50 patients, 35 patients were enrolled to arm R between December 4, 2015 and August 17, 2017.
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