NCT06357975 · 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 crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Treatment (Crizotinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Ineligible or Never Started
- reasons
- group Id
- FG000
- num Subjects
- 12
- type
- Mutation Status Not Confirmed
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 19
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Other Complicating Disease
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- On Treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 44
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 40
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 28
- comment
- Primary efficacy analysis set
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 44
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- For subprotocol C1, patients were required to have MET amplification defined as ≥7 copies/cell as identified by the Oncomine® Assay, or the Oncomine® Assay equivalent of 7 or greater as identified by a Designated Laboratory.
- recruitment Details
- Subprotocol C1 was activated on May 31, 2016. Forty-four patients were enrolled on EAY131-C1 between July 29, 2016, and November 12, 2021. Thirteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 31 on the basis of the outside assay results.
Complete source fields
- groups
- description
- Patients receive crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- FG000
- title
- Treatment (Crizotinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Ineligible or Never Started
- reasons
- group Id
- FG000
- num Subjects
- 12
- type
- Mutation Status Not Confirmed
- reasons
- group Id
- FG000
- num Subjects
- 4
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 19
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Other Complicating Disease
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- On Treatment
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 44
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 40
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 28
- comment
- Primary efficacy analysis set
- type
- Eligible, Treated and Mutation Status Confirmed
- achievements
- group Id
- FG000
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 44
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- For subprotocol C1, patients were required to have MET amplification defined as ≥7 copies/cell as identified by the Oncomine® Assay, or the Oncomine® Assay equivalent of 7 or greater as identified by a Designated Laboratory.
- recruitment Details
- Subprotocol C1 was activated on May 31, 2016. Forty-four patients were enrolled on EAY131-C1 between July 29, 2016, and November 12, 2021. Thirteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 31 on the basis of the outside assay results.
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