TriangleNCT02807272 · 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
- 1 year
What was measured
The PFS time was defined as the time from the date of consent signed to the date of documented disease progression or death due to any cause, whichever occurred first. Participants without progression or death were censored at the date of the last disease assessment. Participants who received subsequent anticancer therapy were censored at the date of the last disease assessment before subsequent anticancer therapy. The Kaplan-Meier product-limit method was used to estimate the 1-year PFS rate, as well as the corresponding 95% CI.
Analysis population: PP Analysis Set: Included participants who received at least 1 dose of tipifarnib and had a baseline disease assessment and at least 1 post-baseline disease assessment.
Groups in this outcome
KRAS/NRAS WT
Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.
KRAS/NRAS Mut
Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.
KRAS/NRAS Missing
Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.
CXCR4/2 High
Participants with MDS/MPN received tipifarnib at a starting dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.
CXCR4/2 Low
Participants with MDS/MPN received tipifarnib at a starting dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.
| Group | Source count |
|---|---|
| KRAS/NRAS WT | 21 |
| KRAS/NRAS Mut | 9 |
| KRAS/NRAS Missing | 2 |
| CXCR4/2 High | 1 |
| CXCR4/2 Low | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 9.2 | Not reported | 3.6 | 12.9 | Not reported |
| KRAS/NRAS Mut | 4.1 | Not reported | 2.1 | NA | Upper CI not calculable due to insufficient number of events. |
| KRAS/NRAS Missing | 10.0 | Not reported | NA | NA | Upper and lower CI not calculable due to insufficient number of events. |
| CXCR4/2 High | NA | Not reported | NA | NA | Median and CI not calculable due to insufficient number of events. |
| CXCR4/2 Low | 11.0 | Not reported | 1.7 | NA | Upper CI not calculable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.6
- upper Limit
- 12.9
- value
- 9.2
- comment
- Upper CI not calculable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 2.1
- upper Limit
- NA
- value
- 4.1
- comment
- Upper and lower CI not calculable due to insufficient number of events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 10.0
- comment
- Median and CI not calculable due to insufficient number of events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper CI not calculable due to insufficient number of events.
- group Id
- OG004
- lower Limit
- 1.7
- upper Limit
- NA
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- units
- Participants
- description
- The PFS time was defined as the time from the date of consent signed to the date of documented disease progression or death due to any cause, whichever occurred first. Participants without progression or death were censored at the date of the last disease assessment. Participants who received subsequent anticancer therapy were censored at the date of the last disease assessment before subsequent anticancer therapy. The Kaplan-Meier product-limit method was used to estimate the 1-year PFS rate, as well as the corresponding 95% CI.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.
- id
- OG000
- title
- KRAS/NRAS WT
- description
- Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.
- id
- OG001
- title
- KRAS/NRAS Mut
- description
- Participants with CMML received tipifarnib at a starting dose of 1200 mg, BID, for 7 days in alternating weeks (Days 1 to 7 and Days 15 to 21) in 28-day cycles.
- id
- OG002
- title
- KRAS/NRAS Missing
- description
- Participants with MDS/MPN received tipifarnib at a starting dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.
- id
- OG003
- title
- CXCR4/2 High
- description
- Participants with MDS/MPN received tipifarnib at a starting dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.
- id
- OG004
- title
- CXCR4/2 Low
- param Type
- MEDIAN
- population Description
- PP Analysis Set: Included participants who received at least 1 dose of tipifarnib and had a baseline disease assessment and at least 1 post-baseline disease assessment.
- reporting Status
- POSTED
- time Frame
- 1 year
- 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