TriangleNCT01871727 · OUTCOME
Lead-In Part: Duration of Response (DOR) Per Investigator Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months)
What was measured
DOR per investigator assessment was defined as the time from date when criteria for response (CR or PR) was first met until the date of the first documentation of disease progression (PD) or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir.
Analysis population: Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead in part.
Groups in this outcome
Lead-In Part: E7777 6 mcg/kg
Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 9 mcg/kg
Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
Lead-In Part: E7777 12 mcg/kg
Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
Lead-In Part: E7777 15 mcg/kg
Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
| Group | Source count |
|---|---|
| Lead-In Part: E7777 6 mcg/kg | 1 |
| Lead-In Part: E7777 9 mcg/kg | 4 |
| Lead-In Part: E7777 12 mcg/kg | 3 |
| Lead-In Part: E7777 15 mcg/kg | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-In Part: E7777 6 mcg/kg | 43.0 | Not reported | 43 | 43 | Not reported |
| Lead-In Part: E7777 9 mcg/kg | 106.0 | Not reported | 71 | 134 | Not reported |
| Lead-In Part: E7777 12 mcg/kg | 113.0 | Not reported | 92 | 351 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 43
- upper Limit
- 43
- value
- 43.0
- group Id
- OG001
- lower Limit
- 71
- upper Limit
- 134
- value
- 106.0
- group Id
- OG002
- lower Limit
- 92
- upper Limit
- 351
- value
- 113.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- DOR per investigator assessment was defined as the time from date when criteria for response (CR or PR) was first met until the date of the first documentation of disease progression (PD) or date of death from any cause. The tumor assessment was based on GRS Olsen 2011 criteria. CR was defined as disappearance of all evidence of disease and PR was defined as regression of measurable disease and no new sites. PD was defined as any new lesion or unequivocally increase of previously involved sites from nadir.
- dispersion Type
- Full Range
- groups
- description
- Participants were treated with E7777 6 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG000
- title
- Lead-In Part: E7777 6 mcg/kg
- description
- Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minute on 5 consecutive days during every 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.
- id
- OG001
- title
- Lead-In Part: E7777 9 mcg/kg
- description
- Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG002
- title
- Lead-In Part: E7777 12 mcg/kg
- description
- Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.
- id
- OG003
- title
- Lead-In Part: E7777 15 mcg/kg
- param Type
- MEDIAN
- population Description
- Lead-in analysis set included all participants enrolled in the Lead-in part. Here, 'overall number of participants analyzed' were those who had CR or PR in lead in part.
- reporting Status
- POSTED
- time Frame
- From the date of first documentation of CR or PR until date of the first documentation of PD or death due to any cause (Up to 1 year 2 months)
- title
- Lead-In Part: Duration of Response (DOR) Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice