NCT03386513 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants received IMGN632 at a dose of 0.015 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
- id
- FG000
- title
- Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG001
- title
- Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG002
- title
- Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG003
- title
- Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG004
- title
- Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG005
- title
- Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- FG006
- title
- Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- FG007
- title
- Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- FG008
- title
- Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG009
- title
- Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG010
- title
- Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 2
- group Id
- FG010
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- type
- Sponsor Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- type
- Investigator Decision
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 12
- group Id
- FG009
- num Subjects
- 76
- group Id
- FG010
- num Subjects
- 9
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- type
- Other than Specified
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 13
- group Id
- FG010
- num Subjects
- 0
- type
- Ongoing in Trial at Time of Data Cutoff
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 13
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 104
- group Id
- FG010
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 13
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 104
- group Id
- FG010
- num Subjects
- 10
- type
- Received at least 1 dose of study drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 8
- group Id
- FG010
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 11
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 96
- group Id
- FG010
- num Subjects
- 10
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The study is ongoing and reports data up to the primary analysis data cut-off date (up to approximately 81 months).
Complete source fields
- groups
- description
- Participants received IMGN632 at a dose of 0.015 milligrams (mg)/kilogram (kg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
- id
- FG000
- title
- Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG001
- title
- Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG002
- title
- Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG003
- title
- Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG004
- title
- Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG005
- title
- Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- FG006
- title
- Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- FG007
- title
- Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- FG008
- title
- Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG009
- title
- Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- FG010
- title
- Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 2
- group Id
- FG010
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 3
- group Id
- FG010
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- type
- Sponsor Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- type
- Investigator Decision
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 10
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 12
- group Id
- FG009
- num Subjects
- 76
- group Id
- FG010
- num Subjects
- 9
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 1
- group Id
- FG010
- num Subjects
- 0
- type
- Other than Specified
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 13
- group Id
- FG010
- num Subjects
- 0
- type
- Ongoing in Trial at Time of Data Cutoff
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 13
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 104
- group Id
- FG010
- num Subjects
- 10
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 12
- group Id
- FG002
- num Subjects
- 13
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 104
- group Id
- FG010
- num Subjects
- 10
- type
- Received at least 1 dose of study drug
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 8
- group Id
- FG010
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 11
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 7
- group Id
- FG004
- num Subjects
- 5
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 6
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 96
- group Id
- FG010
- num Subjects
- 10
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The study is ongoing and reports data up to the primary analysis data cut-off date (up to approximately 81 months).
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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