TriangleNCT02464228 · 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 3 years
What was measured
DOR was defined as the time (in months) from the start date of the objective response to the first date of either documented PD or death. No data imputations were conducted for missing data. In the event of a maintained response, the DOR was censored at the last evaluable non-PD assessment. The DOR was analyzed using the KM method. 95% CIs were calculated using Hall-Wellner Method.
Analysis population: The FAS Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.
Groups in this outcome
Cohort AITL
Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
Cohort PTCL-NOS
Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
Cohort PTCL-NOS, CXCL12+
Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
Cohort Other
Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
| Group | Source count |
|---|---|
| Cohort AITL | 18 |
| Cohort PTCL-NOS | 1 |
| Cohort PTCL-NOS, CXCL12+ | 4 |
| Cohort Other | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort AITL | 7.8 | Not reported | 2.0 | 16.3 | Not reported |
| Cohort PTCL-NOS | 1.0 | Not reported | NA | NA | Lower 95% CI could not be estimated as there were too few participants with events that impacted the estimate of DOR function and there was no variation as per the pre-specified analysis in the SAP. |
| Cohort PTCL-NOS, CXCL12+ | 2.8 | Not reported | 2.0 | NA | Upper 95% CI was not reached as there were too few participants with events that impacted the estimate of DOR function. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 16.3
- value
- 7.8
- comment
- Lower 95% CI could not be estimated as there were too few participants with events that impacted the estimate of DOR function and there was no variation as per the pre-specified analysis in the SAP.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 1.0
- comment
- Upper 95% CI was not reached as there were too few participants with events that impacted the estimate of DOR function.
- group Id
- OG002
- lower Limit
- 2.0
- upper Limit
- NA
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- DOR was defined as the time (in months) from the start date of the objective response to the first date of either documented PD or death. No data imputations were conducted for missing data. In the event of a maintained response, the DOR was censored at the last evaluable non-PD assessment. The DOR was analyzed using the KM method. 95% CIs were calculated using Hall-Wellner Method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects with AITL received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
- id
- OG000
- title
- Cohort AITL
- description
- Subjects with PTCL-NOS (not including subjects with PTCL-NOS CXCL12+) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
- id
- OG001
- title
- Cohort PTCL-NOS
- description
- Subjects with PTCL-NOS CXCL12+ (not including subjects with PTCL-NOS) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
- id
- OG002
- title
- Cohort PTCL-NOS, CXCL12+
- description
- Subjects with other indications (including ALCL-ALK negative and PTCL-subtype not specified per protocol) received tipifarnib as monotherapy. Tipifarnib was administered with food at a starting dose of 300 mg orally BID on Days 1 - 21 of 28-day treatment cycles. In the absence of unmanageable toxicity, treatment may have been continued as long as the investigator considered that the treatment was providing clinical benefit for up to 12 months since the subject's enrollment. Treatment may have continued beyond 12 months upon agreement by the investigator and sponsor if there was documented evidence of sustained clinical benefit.
- id
- OG003
- title
- Cohort Other
- param Type
- MEDIAN
- population Description
- The FAS Population excluding subjects for the following reasons: no baseline data; failure to receive at least 1 dose of tipifarnib; no post-baseline endpoint data subsequent to at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to approximately 3 years
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice