NCT06360575 · 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
- 6
- type
- Ineligible or Never Started
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 7
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 20
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 14
- 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
- 20
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- For subprotocol C2, patients were required to have MET Exon 14 deletion by the Oncomine® Assay RNA-sequencing approach, and confirmation was performed retrospectively at the DNA level using Anchored Multiplex PCR, utilizing a custom targeted DNA sequencing panel and analysis pipeline that permitted analysis of the MET exon 14 coding region and surrounding intronic sequences.
- recruitment Details
- Subprotocol C2 was activated on May 31, 2016. Twenty patients were enrolled on EAY131-C2 between July 20, 2016, and March 16, 2020. Sixteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 4 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
- 6
- type
- Ineligible or Never Started
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 7
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Physician Decision
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 20
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 18
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 14
- 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
- 20
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- For subprotocol C2, patients were required to have MET Exon 14 deletion by the Oncomine® Assay RNA-sequencing approach, and confirmation was performed retrospectively at the DNA level using Anchored Multiplex PCR, utilizing a custom targeted DNA sequencing panel and analysis pipeline that permitted analysis of the MET exon 14 coding region and surrounding intronic sequences.
- recruitment Details
- Subprotocol C2 was activated on May 31, 2016. Twenty patients were enrolled on EAY131-C2 between July 20, 2016, and March 16, 2020. Sixteen patients were enrolled on the basis of the results from the NCI-MATCH assay and 4 on the basis of the outside assay results.
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Preserved source evidence · Not medical advice
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