TriangleNCT01494506 · OUTCOME
Percentage of Patients With Tumor Marker (CA 19-9) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percent of participants with TMR
- Interval / dispersion
- Not reported
- Time frame
- Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
What was measured
Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
Analysis population: Patients with elevated baseline CA19-9 value (\> 30 U/mL) who received study drug.
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) | 123 |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 105 |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 97 |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 81 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MM-398 Arm A (Mono Therapy Comparison) | 23.6 | Not reported | Not reported | Not reported | Not reported |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 11.4 | Not reported | Not reported | Not reported | Not reported |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 28.9 | Not reported | Not reported | Not reported | Not reported |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 8.6 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.024
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.024
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 23.6
- group Id
- OG001
- value
- 11.4
- group Id
- OG002
- value
- 28.9
- group Id
- OG003
- value
- 8.6
- denoms
- counts
- group Id
- OG000
- value
- 123
- group Id
- OG001
- value
- 105
- group Id
- OG002
- value
- 97
- group Id
- OG003
- value
- 81
- units
- Participants
- description
- Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.
- 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
- NUMBER
- population Description
- Patients with elevated baseline CA19-9 value (\> 30 U/mL) who received study drug.
- reporting Status
- POSTED
- time Frame
- Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months
- title
- Percentage of Patients With Tumor Marker (CA 19-9) Response
- type
- SECONDARY
- unit Of Measure
- percent of participants with TMR
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice