TriangleNCT01482962 · OUTCOME
Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
What was measured
ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.
Analysis population: Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC.
Groups in this outcome
Alisertib
Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
Pralatrexate, or Romidepsin, or Gemcitabine
Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
| Group | Source count |
|---|---|
| Alisertib | 102 |
| Pralatrexate, or Romidepsin, or Gemcitabine | 92 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 33 | Not reported | 24 | 43 | Not reported |
| Pralatrexate, or Romidepsin, or Gemcitabine | 45 | Not reported | 34 | 55 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.33
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.038
- p Value Comment
- P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.
- param Type
- Odds Ratio (OR)
- param Value
- 0.60
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.33
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.038
- p Value Comment
- P-value was stratified using disease type, International Prognostic Index (IPI) Score and region as stratification factors.
- param Type
- Odds Ratio (OR)
- param Value
- 0.60
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24
- upper Limit
- 43
- value
- 33
- group Id
- OG001
- lower Limit
- 34
- upper Limit
- 55
- value
- 45
- denoms
- counts
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- ORR was defined as the percentage of participants who achieve Complete Response (CR) or Partial Response (PR) as assessed by the IRC using International Working Group (IWG) criteria. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Alisertib 50 mg, enteric-coated tablet formulation, orally, twice daily for 7 consecutive days (Cycle Days 1-7) in a 21-day cycle (Up to 148 Weeks).
- id
- OG000
- title
- Alisertib
- description
- Pralatrexate 30 mg/m\^2, intravenous (IV) push over 3 to 5 minutes, once weekly, for 6 weeks in 7-week cycles with concurrent vitamin B12 and folic acid supplementation. Cycles were repeated every 7-weeks provided the participant continued to benefit from and tolerate the therapy (Up to 115 Weeks), or Gemcitabine 1,000 mg/m\^2 over 30 minutes, intravenously, on Days 1, 8, and 15 of a 28-day cycle until the absence of disease progression or unacceptable toxicity (Up to 32 Weeks), or Romidepsin 14 mg/m\^2, intravenously over a 4-hour period, on Days 1, 8, and 15 of a 28-cycle. Cycles were repeated every 28 days provided the patient continued to benefit from and tolerate the therapy (Up to 30 Weeks).
- id
- OG001
- title
- Pralatrexate, or Romidepsin, or Gemcitabine
- param Type
- NUMBER
- population Description
- Response-evaluable population, participants with peripheral T-cell lymphoma confirmed by an independent hematopathology central review, with measurable disease at Baseline, who received at least 1 dose of alisertib or comparator and had postbaseline response assessment of CR, PR, stable disease (SD) or progressive disease (PD) by the IRC.
- reporting Status
- POSTED
- time Frame
- Every 8 weeks from date of first dose treatment; every 12 weeks after 40 week assessment; at end of treatment visit until progressive disease. Duration is approximately 3 years
- title
- Overall Response Rate (ORR) Based on Independent Review Committee (IRC) Assessment
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice