NCT04211337 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- 160 milligrams (mg) Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
- id
- FG000
- title
- Selpercatinib - Treatment A (TRT A)
- description
- 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
- id
- FG001
- title
- Cabozantinib or Vandetanib - Treatment B (TRT B)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 175
- group Id
- FG001
- num Subjects
- 40
- type
- On Treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 193
- group Id
- FG001
- num Subjects
- 98
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 193
- group Id
- FG001
- num Subjects
- 97
- type
- Received at Least One Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 56
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 175
- group Id
- FG001
- num Subjects
- 42
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- If a participant has a recorded death on study, or is alive and being followed but off treatment, then the participant can be considered to be study completer. Participants randomized to the Cabozantinib or Vandetanib arm will be allowed to crossover to receive the investigational product at the time of Blinded Independent Committee Review (BICR) confirmed radiographic progression.
Complete source fields
- groups
- description
- 160 milligrams (mg) Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 milligrams per square meter (mg/m2) BID (not to exceed 160 mg BID).
- id
- FG000
- title
- Selpercatinib - Treatment A (TRT A)
- description
- 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
- id
- FG001
- title
- Cabozantinib or Vandetanib - Treatment B (TRT B)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 175
- group Id
- FG001
- num Subjects
- 40
- type
- On Treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 2
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 193
- group Id
- FG001
- num Subjects
- 98
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 193
- group Id
- FG001
- num Subjects
- 97
- type
- Received at Least One Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 18
- group Id
- FG001
- num Subjects
- 56
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 175
- group Id
- FG001
- num Subjects
- 42
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- If a participant has a recorded death on study, or is alive and being followed but off treatment, then the participant can be considered to be study completer. Participants randomized to the Cabozantinib or Vandetanib arm will be allowed to crossover to receive the investigational product at the time of Blinded Independent Committee Review (BICR) confirmed radiographic progression.
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