TriangleNCT01494506 · OUTCOME
Overall Survival
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
- From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.
What was measured
Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
Analysis population: Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.
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) | 4.9 | Not reported | 4.23 | 5.62 | Not reported |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 4.2 | Not reported | 3.58 | 4.86 | Not reported |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 6.1 | Not reported | 4.76 | 8.87 | Not reported |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 4.2 | Not reported | 3.29 | 5.32 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.28
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9416
- param Type
- Hazard Ratio (HR)
- param Value
- 0.99
- statistical Comment
- Unstratified logrank test.
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.67
- statistical Comment
- Unstratified logrank test.
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.77
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.28
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9416
- param Type
- Hazard Ratio (HR)
- param Value
- 0.99
- statistical Comment
- Unstratified logrank test.
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.67
- statistical Comment
- Unstratified logrank test.
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.23
- upper Limit
- 5.62
- value
- 4.9
- group Id
- OG001
- lower Limit
- 3.58
- upper Limit
- 4.86
- value
- 4.2
- group Id
- OG002
- lower Limit
- 4.76
- upper Limit
- 8.87
- value
- 6.1
- group Id
- OG003
- lower Limit
- 3.29
- upper Limit
- 5.32
- value
- 4.2
- 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
- Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis. The comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.
- 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
- Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.
- reporting Status
- POSTED
- time Frame
- From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.
- title
- Overall Survival
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice