NCT00536575 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
- id
- FG000
- title
- Sorafenib/Bortezomib
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 13
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 2
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
- id
- FG000
- title
- Sorafenib/Bortezomib
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- type
- Death
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 13
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 11
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 2
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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