TriangleNCT02414139 · OUTCOME
DOR by Investigator Assessment
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
- Up to approximately 5 years
What was measured
Time from the date of the first documented CR or PR per RECIST 1.1 by investigator assessment to the first documented progression or death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
Analysis population: Participants with confirmed CR or PR by investigator assessment in FAS.
Groups in this outcome
Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
| Group | Source count |
|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 19 |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 3 |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 5 |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 1 |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 30 |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 6 |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 17 |
| Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L) | 0 |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 14 |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 18 |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 44 |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 35 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L) | 6.80 | Not reported | 4.21 | 20.73 | Not reported |
| Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L) | 6.93 | Not reported | 5.75 | 8.34 | Not reported |
| Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L) | 19.48 | Not reported | 2.83 | NA | NA: not estimable due to the insufficient number of participants with events |
| Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L) | 6.93 | Not reported | NA | NA | NA: not estimable due to the insufficient number of participants with events |
| Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 8.31 | Not reported | 4.34 | 12.06 | Not reported |
| Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L) | 9.66 | Not reported | 4.01 | 17.08 | Not reported |
| Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L) | 13.83 | Not reported | 4.27 | 25.33 | Not reported |
| Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L) | 14.57 | Not reported | 4.17 | 27.60 | Not reported |
| Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L) | 15.21 | Not reported | 6.77 | 31.77 | Not reported |
| Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L) | 8.38 | Not reported | 5.55 | 13.80 | Not reported |
| Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L) | 13.96 | Not reported | 9.33 | 22.18 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.21
- upper Limit
- 20.73
- value
- 6.80
- group Id
- OG001
- lower Limit
- 5.75
- upper Limit
- 8.34
- value
- 6.93
- comment
- NA: not estimable due to the insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 2.83
- upper Limit
- NA
- value
- 19.48
- comment
- NA: not estimable due to the insufficient number of participants with events
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.93
- group Id
- OG004
- lower Limit
- 4.34
- upper Limit
- 12.06
- value
- 8.31
- group Id
- OG005
- lower Limit
- 4.01
- upper Limit
- 17.08
- value
- 9.66
- group Id
- OG006
- lower Limit
- 4.27
- upper Limit
- 25.33
- value
- 13.83
- group Id
- OG008
- lower Limit
- 4.17
- upper Limit
- 27.60
- value
- 14.57
- group Id
- OG009
- lower Limit
- 6.77
- upper Limit
- 31.77
- value
- 15.21
- group Id
- OG010
- lower Limit
- 5.55
- upper Limit
- 13.80
- value
- 8.38
- group Id
- OG011
- lower Limit
- 9.33
- upper Limit
- 22.18
- value
- 13.96
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 30
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 17
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 14
- group Id
- OG009
- value
- 18
- group Id
- OG010
- value
- 44
- group Id
- OG011
- value
- 35
- units
- Participants
- description
- Time from the date of the first documented CR or PR per RECIST 1.1 by investigator assessment to the first documented progression or death due to any cause for patients with confirmed PR or CR. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals was reported. If a subject did not have an event, DOR was censored at the date of last adequate tumor assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, any pathological lymph nodes assigned as target and non-target lesions must have a reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Pre-treated patients with MET GCN ≥ 10 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG000
- title
- Cohort 1a: Pre-treated Patients With MET GCN ≥ 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 6 and \< 10 treated with INC280 at 400 mg BID as second or third line (2/3L)
- id
- OG001
- title
- Cohort 1b: Pre-treated Patients With MET GCN ≥ 6 and < 10 (2/3L)
- description
- Pre-treated patients with MET GCN ≥ 4 and \< 6 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG002
- title
- Cohort 2: Pre-treated Patients With MET GCN ≥ 4 and < 6 (2/3L)
- description
- Pre-treated patients with MET GCN \< 4 treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG003
- title
- Cohort 3: Pre-treated Patients With MET GCN < 4 (2/3L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L)
- id
- OG004
- title
- Cohort 4: Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- Treatment-naïve patients with MET GCN ≥10 treated with INC280 at 400mg BID as first-line (1L)
- id
- OG005
- title
- Cohort 5a: Treatment-naïve Patients With MET GCN ≥10 (1L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L)
- id
- OG006
- title
- Cohort 5b: Treatment-naïve Patients With MET Mutation Regardless of MET GCN (1L)
- description
- Pre-treated patients with MET GCN ≥ 10 without MET mutation treated with INC280 at 400 mg BID as second line (2L) (expansion cohort of Cohort 1a)
- id
- OG007
- title
- Cohort 6.1 (Expansion of Cohort 1a): Pre-treated Patients MET GCN ≥ 10 Without MET Mutation (2L)
- description
- Pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as second line (2L)(expansion of Cohort 4)
- id
- OG008
- title
- Cohort 6.2 (Expansion of Cohort 4): Pre-treated Patients With MET Mutation (2L)
- description
- Treatment-naïve patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as first line (1L) (expansion cohort of Cohort 5b)
- id
- OG009
- title
- Cohort 7 (Expansion of Cohort 5b): Treatment-naïve With MET Mutation Regardless of MET GCN (1L)
- description
- All pre-treated patients with MET mutation regardless of MET GCN treated with INC280 at 400mg BID as second or third line (2/3L). (Participants from Cohort 4 and Cohort 6.2)
- id
- OG010
- title
- Cohort 4 + Cohort 6.2: All Pre-treated Patients With MET Mutation Regardless of MET GCN (2/3L)
- description
- All treatment naive patients with MET mutation regardless of MET GCN treated with INC280 at 400 mg BID as first line (1L) (Participants from Cohort 5b and Cohort 7)
- id
- OG011
- title
- Cohort 5b + Cohort 7: All Treatment-naive With MET Mutation Regardless of MET GCN (1L)
- param Type
- MEDIAN
- population Description
- Participants with confirmed CR or PR by investigator assessment in FAS.
- reporting Status
- POSTED
- time Frame
- Up to approximately 5 years
- title
- DOR by Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice