NCT06390852 · 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 larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Larotrectinib [LOXO-101])
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Mutation Status Not Confirmed
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Still on Therapy
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 16
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 16
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 15
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 12
- 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
- 16
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Patients were assigned to subprotocol Z1E if an NTRK fusion-positive tumor was identified. The mutation status was determined by an NCI-MATCH approved laboratory for all 16 patients in this arm. These cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol Z1E was activated on March 13, 2017. Between August 21, 2017, and July 8, 2021, 16 patients were enrolled in subprotocol Z1E. All were enrolled on the basis of the outside assay results.
Complete source fields
- groups
- description
- Patients receive larotrectinib (LOXO-101) 100 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients also undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Larotrectinib [LOXO-101])
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Ineligible
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Mutation Status Not Confirmed
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 3
- type
- Still on Therapy
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 16
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 16
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 15
- type
- Eligible
- achievements
- group Id
- FG000
- num Subjects
- 12
- 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
- 16
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Patients were assigned to subprotocol Z1E if an NTRK fusion-positive tumor was identified. The mutation status was determined by an NCI-MATCH approved laboratory for all 16 patients in this arm. These cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol Z1E was activated on March 13, 2017. Between August 21, 2017, and July 8, 2021, 16 patients were enrolled in subprotocol Z1E. All were enrolled on the basis of the outside assay results.
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Independent clinical review pending · Not medical advice
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