TriangleNCT02903914 · OUTCOME
Progression-free Survival (PFS)
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
- Until disease progression/study discontinuation (up to approximately 5 years)
What was measured
PFS was defined as the length of time between the date of the first dose and the earlier of death or progressive disease as assessed by RECIST v1.1. Pleural mesothelioma was evaluated using modified RECIST criteria. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. In renally impaired participants, the 50 mg dose has comparable exposure to 100 mg in participants with normal renal function. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.
Analysis population: PFS Efficacy Evaluable Population (Full Analysis Set): all participants who received at least 1 dose of INCB001158 or pembrolizumab. One participant was to be treated with INCB001158 100 mg + pembrolizumab but actually received INCB001158 75 mg + pembrolizumab. For PFS analysis, this participant was analyzed in their planned treatment group (INCB001158 100 mg + pembrolizumab) rather than in the actual treatment group.
Groups in this outcome
Part 1A: INCB001158 50 mg
INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 75 mg
INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
Part 1A: INCB001158 150 mg
INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
Part 1B: INCB001158 50 mg + Pembrolizumab
INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
Part 1B: INCB001158 75 mg + Pembrolizumab
INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
Part 1B: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
Part 2: INCB001158 100 mg
INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
| Group | Source count |
|---|---|
| Part 1A: INCB001158 50 mg | 8 |
| Part 1A: INCB001158 75 mg | 7 |
| Part 1A: INCB001158 100 mg | 8 |
| Part 1A: INCB001158 150 mg | 7 |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 10 |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 13 |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 11 |
| Part 2: INCB001158 100 mg | 77 |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 119 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1A: INCB001158 50 mg | 1.8 | Not reported | 1.2 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. |
| Part 1A: INCB001158 75 mg | 1.8 | Not reported | 1.2 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. |
| Part 1A: INCB001158 100 mg | 1.8 | Not reported | 1.4 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. |
| Part 1A: INCB001158 150 mg | 2.1 | Not reported | 1.7 | NA | The upper limit of the confidence interval was not estimable because too few participants had disease progression or died. |
| Part 1B: INCB001158 50 mg + Pembrolizumab | 2.1 | Not reported | 0.7 | 6.2 | Not reported |
| Part 1B: INCB001158 75 mg + Pembrolizumab | 2.6 | Not reported | 1.8 | 5.7 | Not reported |
| Part 1B: INCB001158 100 mg + Pembrolizumab | 2.1 | Not reported | 0.6 | 2.3 | Not reported |
| Part 2: INCB001158 100 mg | 1.9 | Not reported | 1.8 | 2.1 | Not reported |
| Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab | 3.0 | Not reported | 2.1 | 4.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
- group Id
- OG000
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.8
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- NA
- value
- 1.8
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
- group Id
- OG002
- lower Limit
- 1.4
- upper Limit
- NA
- value
- 1.8
- comment
- The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
- group Id
- OG003
- lower Limit
- 1.7
- upper Limit
- NA
- value
- 2.1
- group Id
- OG004
- lower Limit
- 0.7
- upper Limit
- 6.2
- value
- 2.1
- group Id
- OG005
- lower Limit
- 1.8
- upper Limit
- 5.7
- value
- 2.6
- group Id
- OG006
- lower Limit
- 0.6
- upper Limit
- 2.3
- value
- 2.1
- group Id
- OG007
- lower Limit
- 1.8
- upper Limit
- 2.1
- value
- 1.9
- group Id
- OG008
- lower Limit
- 2.1
- upper Limit
- 4.1
- value
- 3.0
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 77
- group Id
- OG008
- value
- 119
- units
- Participants
- description
- PFS was defined as the length of time between the date of the first dose and the earlier of death or progressive disease as assessed by RECIST v1.1. Pleural mesothelioma was evaluated using modified RECIST criteria. Participants enrolled in Part 1c had renal impairment. These participants received INCB001158 50 mg + pembrolizumab, which was half the recommended Phase 2 dose of INCB001158. In renally impaired participants, the 50 mg dose has comparable exposure to 100 mg in participants with normal renal function. It was pre-specified to combine Part 1c and Part 3 participants for efficacy analysis based on planned comparable dosing according to renal function.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
- id
- OG000
- title
- Part 1A: INCB001158 50 mg
- description
- INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG001
- title
- Part 1A: INCB001158 75 mg
- description
- INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG002
- title
- Part 1A: INCB001158 100 mg
- description
- INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG003
- title
- Part 1A: INCB001158 150 mg
- description
- INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W).
- id
- OG004
- title
- Part 1B: INCB001158 50 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG005
- title
- Part 1B: INCB001158 75 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG006
- title
- Part 1B: INCB001158 100 mg + Pembrolizumab
- description
- INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors.
- id
- OG007
- title
- Part 2: INCB001158 100 mg
- description
- INCB001158 was administered orally at 100 mg BID (50 mg BID for Part 1c renally impaired participants) in combination with pembrolizumab at 200 mg IV Q3W.
- id
- OG008
- title
- Part 1c and Part 3: INCB001158 100 mg + Pembrolizumab
- param Type
- MEDIAN
- population Description
- PFS Efficacy Evaluable Population (Full Analysis Set): all participants who received at least 1 dose of INCB001158 or pembrolizumab. One participant was to be treated with INCB001158 100 mg + pembrolizumab but actually received INCB001158 75 mg + pembrolizumab. For PFS analysis, this participant was analyzed in their planned treatment group (INCB001158 100 mg + pembrolizumab) rather than in the actual treatment group.
- reporting Status
- POSTED
- time Frame
- Until disease progression/study discontinuation (up to approximately 5 years)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice