TriangleNCT01327612 · OUTCOME
Best Overall Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
What was measured
Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.
Analysis population: Participants who received at least one dose of conatumumab or ganitumab.
Groups in this outcome
20050118: Ganitumab 20 mg/kg
Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
20050171: Conatumumab 0.45 mg/kg
Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
20060295: Conatumumab 3 mg/kg
Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
20060340: Conatumumab 5 mg/kg
Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
| Group | Source count |
|---|---|
| 20050118: Ganitumab 20 mg/kg | 2 |
| 20050171: Conatumumab 0.45 mg/kg | 1 |
| 20060295: Conatumumab 3 mg/kg | 1 |
| 20060340: Conatumumab 5 mg/kg | 1 |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 2 |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 3 |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 2 |
Reported measurements
Source class 1
Complete response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20050171: Conatumumab 0.45 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 20060295: Conatumumab 3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060340: Conatumumab 5 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 1 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Partial response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20050171: Conatumumab 0.45 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060295: Conatumumab 3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060340: Conatumumab 5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 1 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 1 | Not reported | Not reported | Not reported | Not reported |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| 20050171: Conatumumab 0.45 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060295: Conatumumab 3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| 20060340: Conatumumab 5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 2 | Not reported | Not reported | Not reported | Not reported |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Progressive disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 20050118: Ganitumab 20 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20050171: Conatumumab 0.45 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060295: Conatumumab 3 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060340: Conatumumab 5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
| 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- Complete response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- title
- Partial response
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- title
- Stable disease
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- title
- Progressive disease
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- units
- Participants
- description
- Radiological assessments to evaluate disease extent (with change compared to nadir from the parent protocol) were performed at regular intervals, at a minimum once every 6 months or more frequently if clinically indicated (starting from their last scan on the parent protocol), per standard of care (SOC) at each facility. Tumor response was assessed by the Investigator as either complete response, partial response, stable disease, or progressive disease.
- groups
- description
- Ganitumab 20 mg/kg once every 4 weeks by intravenous infusion.
- id
- OG000
- title
- 20050118: Ganitumab 20 mg/kg
- description
- Conatumumab 0.45 mg/kg every 2 weeks by intravenous infusion.
- id
- OG001
- title
- 20050171: Conatumumab 0.45 mg/kg
- description
- Conatumumab 3 mg/kg every 3 weeks by intravenous infusion.
- id
- OG002
- title
- 20060295: Conatumumab 3 mg/kg
- description
- Conatumumab 5 mg/kg once every 3 weeks by intravenous infusion.
- id
- OG003
- title
- 20060340: Conatumumab 5 mg/kg
- description
- Conatumumab 2 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy and bevacizumab 5 mg/kg once every 2 weeks.
- id
- OG004
- title
- 20060464: Conatumumab 2 mg/kg + mFOLFOX6 + Bevacizumab
- description
- Conatumumab 10 mg/kg once every 2 weeks by intravenous infusion in addition to modified FOLFOX6 chemotherapy, with or without bevacizumab 5 mg/kg once every 2 weeks.
- id
- OG005
- title
- 20060464: Conatumumab 10 mg/kg + mFOLFOX6 ± Bevacizumab
- description
- Conatumumab 15 mg/kg + ganitumab 18 mg/kg once every 3 weeks by intravenous infusion.
- id
- OG006
- title
- 20070411: Conatumumab 15 mg/kg + Ganitumab 18 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least one dose of conatumumab or ganitumab.
- reporting Status
- POSTED
- time Frame
- Approximately every 6 months until end of treatment; median duration of treatment with conatumumab was 1190.5 days and 1163.0 days for ganitumab.
- title
- Best Overall Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice