NCT06390826 · 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 sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 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 ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Sunitinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Never Start Protocol Therapy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 9
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 9
- 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
- 10
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Eligible patients for arm-V must have a somatic cKIT mutation in exon 9, 11, 13 or 14, excluding exon 17 or 18 mutations, activating PDGFRA or PDGFRB variants and fusions, or another aberration as identified in the protocol. The mutation status was determined by an NCI-MATCH approved laboratory for 6 patients in this arm, these cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol V was activated on August 12, 2015. A total of 10 patients were enrolled between November 1, 2016 and May 21, 2020. Four patients were enrolled on the basis of the results from the NCI-MATCH assay and 6 on the basis of the outside assay results.
Complete source fields
- groups
- description
- Patients receive sunitinib 50 mg PO QD on days 1-28 of each cycle. Cycles repeat every 42 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 ECHO or nuclear study throughout the trial as clinically necessary. Patients undergo biopsies and blood sample collection on study.
- id
- FG000
- title
- Treatment (Sunitinib)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Never Start Protocol Therapy
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 8
- type
- Disease Progression
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 9
- type
- Started Protocol Therapy
- achievements
- group Id
- FG000
- num Subjects
- 9
- 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
- 10
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Eligible patients for arm-V must have a somatic cKIT mutation in exon 9, 11, 13 or 14, excluding exon 17 or 18 mutations, activating PDGFRA or PDGFRB variants and fusions, or another aberration as identified in the protocol. The mutation status was determined by an NCI-MATCH approved laboratory for 6 patients in this arm, these cases had to be confirmed to be used in primary analysis.
- recruitment Details
- Subprotocol V was activated on August 12, 2015. A total of 10 patients were enrolled between November 1, 2016 and May 21, 2020. Four patients were enrolled on the basis of the results from the NCI-MATCH assay and 6 on the basis of the outside assay results.
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Preserved source evidence · Not medical advice
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