TriangleNCT01494506 · OUTCOME
Time to Treatment Failure
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
- Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months
What was measured
Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
Analysis population: ITT Population
Groups in this outcome
MM-398 Arm A (Mono Therapy Comparison)
• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
5-FU + Leucovorin (Combo Therapy Comparison)
* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
| Group | Source count |
|---|---|
| MM-398 Arm A (Mono Therapy Comparison) | 151 |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 149 |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 117 |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 119 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MM-398 Arm A (Mono Therapy Comparison) | 1.7 | Not reported | 1.5 | 2.7 | Not reported |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 1.4 | Not reported | 1.3 | 1.4 | Not reported |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 2.3 | Not reported | 1.6 | 2.8 | Not reported |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 1.4 | Not reported | 1.3 | 1.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1008
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- statistical Comment
- Unstratified log rank test.
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.78
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Comment
- Unstratified log rank test
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1008
- param Type
- Hazard Ratio (HR)
- param Value
- 0.82
- statistical Comment
- Unstratified log rank test.
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.78
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0002
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Comment
- Unstratified log rank test
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 2.7
- value
- 1.7
- group Id
- OG001
- lower Limit
- 1.3
- upper Limit
- 1.4
- value
- 1.4
- group Id
- OG002
- lower Limit
- 1.6
- upper Limit
- 2.8
- value
- 2.3
- group Id
- OG003
- lower Limit
- 1.3
- upper Limit
- 1.4
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 149
- group Id
- OG002
- value
- 117
- group Id
- OG003
- value
- 119
- units
- Participants
- description
- Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- • MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
- id
- OG000
- title
- MM-398 Arm A (Mono Therapy Comparison)
- description
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- id
- OG001
- title
- 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)
- description
- * MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2. * 5-FU 2400 mg/m2 IV over 46-hours, and * Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks
- id
- OG002
- title
- MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison
- description
- * 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle * Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.
- id
- OG003
- title
- 5-FU + Leucovorin (Combo Therapy Comparison)
- param Type
- MEDIAN
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months
- title
- Time to Treatment Failure
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice