TriangleNCT00819169 · OUTCOME
Progression Free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from first dose up to 24 months
What was measured
Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
Groups in this outcome
Part 1 Cohort 1
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 1 Cohort 2
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 1 Cohort 3
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
Part 2 Cohort 1
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
Part 2 Cohort 2
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
Part 2 Cohort 3
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
Part 2 Cohort 4
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
Part 2 Cohort 5
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
Part 2 Cohort 6
AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
| Group | Source count |
|---|---|
| Part 1 Cohort 1 | 3 |
| Part 1 Cohort 2 | 3 |
| Part 1 Cohort 3 | 3 |
| Part 2 Cohort 1 | 15 |
| Part 2 Cohort 2 | 8 |
| Part 2 Cohort 3 | 16 |
| Part 2 Cohort 4 | 16 |
| Part 2 Cohort 5 | 9 |
| Part 2 Cohort 6 | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 Cohort 1 | 1.4 | Not reported | 1.1 | 15.4 | Not reported |
| Part 1 Cohort 2 | 4.9 | Not reported | 1.6 | 5.5 | Not reported |
| Part 1 Cohort 3 | 1.3 | Not reported | 1.1 | 2.4 | Not reported |
| Part 2 Cohort 1 | 1.6 | Not reported | 1.3 | 3.7 | Not reported |
| Part 2 Cohort 2 | 3.3 | Not reported | 1.9 | 5.4 | Not reported |
| Part 2 Cohort 3 | 1.5 | Not reported | 1.3 | 2.6 | Not reported |
| Part 2 Cohort 4 | 1.4 | Not reported | 1.2 | 2.3 | Not reported |
| Part 2 Cohort 5 | 2.8 | Not reported | 1.6 | 3.9 | Not reported |
| Part 2 Cohort 6 | 1.3 | Not reported | 1.2 | 1.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 15.4
- value
- 1.4
- group Id
- OG001
- lower Limit
- 1.6
- upper Limit
- 5.5
- value
- 4.9
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 2.4
- value
- 1.3
- group Id
- OG003
- lower Limit
- 1.3
- upper Limit
- 3.7
- value
- 1.6
- group Id
- OG004
- lower Limit
- 1.9
- upper Limit
- 5.4
- value
- 3.3
- group Id
- OG005
- lower Limit
- 1.3
- upper Limit
- 2.6
- value
- 1.5
- group Id
- OG006
- lower Limit
- 1.2
- upper Limit
- 2.3
- value
- 1.4
- group Id
- OG007
- lower Limit
- 1.6
- upper Limit
- 3.9
- value
- 2.8
- group Id
- OG008
- lower Limit
- 1.2
- upper Limit
- 1.7
- value
- 1.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 16
- group Id
- OG006
- value
- 16
- group Id
- OG007
- value
- 9
- group Id
- OG008
- value
- 16
- units
- Participants
- description
- Progression-free survival is defined as the number of days from study day 1 (first dose of investigational product) to the first observation of disease progression (by modified RECIST; or clinical progression, whichever came first) or death due to any cause. Disease progression by RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG000
- title
- Part 1 Cohort 1
- description
- AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG001
- title
- Part 1 Cohort 2
- description
- AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle) AMG 479: AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1. AMG 655: AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
- id
- OG002
- title
- Part 1 Cohort 3
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Non-squamous NSCLC
- id
- OG003
- title
- Part 2 Cohort 1
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Squamous Non -Small Cell Lung Cancer (NSCLC)
- id
- OG004
- title
- Part 2 Cohort 2
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Colorectal Cancer (CRC)
- id
- OG005
- title
- Part 2 Cohort 3
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Pancreatic Cancer
- id
- OG006
- title
- Part 2 Cohort 4
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Ovarian Cancer
- id
- OG007
- title
- Part 2 Cohort 5
- description
- AMG 479 18 mg/kg (Q3W) with AMG 655 15 mg/kg (Q3W) Sarcoma
- id
- OG008
- title
- Part 2 Cohort 6
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Time from first dose up to 24 months
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice