TriangleNCT02807272 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 12 months
What was measured
The ORR was estimated based on the number of participants who achieved an objective response (OR) (complete response \[CR\], complete cytogenetic remission \[CCR\], partial remission \[PR\], marrow response \[MR\], or clinical benefit \[CB\] performed by Principal Investigator according to the MDS/MPN International Working Group \[IWG\] criteria).
Analysis population: Per Protocol Analysis Set (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.
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
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 0 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Mut | 0 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Missing | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 High | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 Low | 0 | Not reported | Not reported | Not reported | Not reported |
CCR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 0 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Mut | 1 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Missing | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 High | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 Low | 0 | Not reported | Not reported | Not reported | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 0 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Mut | 0 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Missing | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 High | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 Low | 1 | Not reported | Not reported | Not reported | Not reported |
MR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 2 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Mut | 1 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Missing | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 High | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 Low | 0 | Not reported | Not reported | Not reported | Not reported |
CB
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 1 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Mut | 1 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Missing | 1 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 High | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 Low | 0 | Not reported | Not reported | Not reported | Not reported |
ORR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/NRAS WT | 3 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Mut | 3 | Not reported | Not reported | Not reported | Not reported |
| KRAS/NRAS Missing | 1 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 High | 0 | Not reported | Not reported | Not reported | Not reported |
| CXCR4/2 Low | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- CR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- CCR
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- title
- PR
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- MR
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- CB
- categories
- measurements
- 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
- title
- ORR
- 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 ORR was estimated based on the number of participants who achieved an objective response (OR) (complete response \[CR\], complete cytogenetic remission \[CCR\], partial remission \[PR\], marrow response \[MR\], or clinical benefit \[CB\] performed by Principal Investigator according to the MDS/MPN International Working Group \[IWG\] criteria).
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Per Protocol Analysis Set (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.
- reporting Status
- POSTED
- time Frame
- Up to 12 months
- title
- Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice