TriangleNCT01494506 · OUTCOME
Percentage of Patients With Clinical Benefit Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants with CBR
- Interval / dispersion
- Not reported
- Time frame
- Randomization to treatment discontinuation.The maximum time in follow up was 25 months
What was measured
Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week period.
Analysis population: Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR: * baseline pain intensity ≥ 20 (out of 100) * baseline morphine consumption ≥ 10 mg/day PO morphine equivalents * baseline KPS of 70 to 90 points
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) | 92 |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 80 |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 78 |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 60 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MM-398 Arm A (Mono Therapy Comparison) | 14 | Not reported | Not reported | Not reported | Not reported |
| 5-FU + Leucovorin (Arm B) (Mono Therapy Comparison) | 13 | Not reported | Not reported | Not reported | Not reported |
| MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison | 14 | Not reported | Not reported | Not reported | Not reported |
| 5-FU + Leucovorin (Combo Therapy Comparison) | 12 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.82
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.80
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.82
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.80
- statistical Method
- Fisher Exact
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 78
- group Id
- OG003
- value
- 60
- units
- Participants
- description
- Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either: (a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain. With stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change. Clinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week 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
- Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR: * baseline pain intensity ≥ 20 (out of 100) * baseline morphine consumption ≥ 10 mg/day PO morphine equivalents * baseline KPS of 70 to 90 points
- reporting Status
- POSTED
- time Frame
- Randomization to treatment discontinuation.The maximum time in follow up was 25 months
- title
- Percentage of Patients With Clinical Benefit Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants with CBR
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice