TriangleNCT02807272 · OUTCOME
Duration of Response (DoR)
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 15 months
What was measured
DoR was measured from the date the participant first met the criteria of an OR to the date that the participant progressed or until death from any cause during the period of disease assessments. 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 last disease assessment before subsequent anticancer therapy. The median duration of response and corresponding 95% CI was estimated using the Kaplan Meier method.
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 postbaseline disease assessment. Only participants who met the criteria for an OR and progressed or died were included in the analysis.
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 | 3 |
| KRAS/NRAS Mut | 3 |
| KRAS/NRAS Missing | 1 |
| CXCR4/2 High | 0 |
| CXCR4/2 Low | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 14.6 | Not reported | 2.3 | NA | Upper CI not calculable due to insufficient number of events. |
| KRAS/NRAS Mut | NA | Not reported | 1.9 | NA | Median and upper CI not calculable due to insufficient number of events. |
| KRAS/NRAS Missing | 4.7 | Not reported | NA | NA | Upper and lower CI not calculable due to insufficient number of events. |
| CXCR4/2 Low | NA | Not reported | NA | NA | Median and CI not calculable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper CI not calculable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- NA
- value
- 14.6
- comment
- Median and upper CI not calculable due to insufficient number of events.
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- NA
- value
- NA
- comment
- Upper and lower CI not calculable due to insufficient number of events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 4.7
- comment
- Median and CI not calculable due to insufficient number of events.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- units
- Participants
- description
- DoR was measured from the date the participant first met the criteria of an OR to the date that the participant progressed or until death from any cause during the period of disease assessments. 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 last disease assessment before subsequent anticancer therapy. The median duration of response and corresponding 95% CI was estimated using the Kaplan Meier method.
- 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 postbaseline disease assessment. Only participants who met the criteria for an OR and progressed or died were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Up to approximately 15 months
- title
- Duration of Response (DoR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice