NCT03517449 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
- id
- FG000
- title
- Lenvatinib 20 mg + Pembrolizumab 200 mg
- description
- Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
- id
- FG001
- title
- Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 411
- group Id
- FG001
- num Subjects
- 416
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 411
- group Id
- FG001
- num Subjects
- 416
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- A total of 1178 participants were screened, of which 351 were screen failures and 827 (697 mismatch repair proficient \[pMMR\] participants and 130 MMR deficient \[dMMR\] participants) were enrolled and randomized, out of which 794 participants were treated.
- recruitment Details
- Participants took part in the study at 167 investigative sites in Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Korea, Mexico, New Zealand, Poland, Russia, Spain, Taiwan, Turkey, United Kingdom and the United States
Complete source fields
- groups
- description
- Participants with EC received lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study.
- id
- FG000
- title
- Lenvatinib 20 mg + Pembrolizumab 200 mg
- description
- Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
- id
- FG001
- title
- Treatment of Physician's Choice (TPC): Doxorubicin or Paclitaxel
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 411
- group Id
- FG001
- num Subjects
- 416
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 411
- group Id
- FG001
- num Subjects
- 416
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- A total of 1178 participants were screened, of which 351 were screen failures and 827 (697 mismatch repair proficient \[pMMR\] participants and 130 MMR deficient \[dMMR\] participants) were enrolled and randomized, out of which 794 participants were treated.
- recruitment Details
- Participants took part in the study at 167 investigative sites in Argentina, Australia, Brazil, Canada, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Korea, Mexico, New Zealand, Poland, Russia, Spain, Taiwan, Turkey, United Kingdom and the United States
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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