TriangleNCT03504397 · OUTCOME
Duration Of Response (DOR)
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 date of first response (CR/PR) until 62 months and 18 day
What was measured
DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.PD was defined as development of new, or progression of existing metastases to the primary cancer under the sudy.
Analysis population: FAS - All Objective Responders
Groups in this outcome
mFOLFOX6 + Zolbetuximab
Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
mFOLFOX6+ Placebo
Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
| Group | Source count |
|---|---|
| mFOLFOX6 + Zolbetuximab | 136 |
| mFOLFOX6+ Placebo | 134 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| mFOLFOX6 + Zolbetuximab | 9.00 | Not reported | 7.49 | 10.38 | Not reported |
| mFOLFOX6+ Placebo | 8.11 | Not reported | 6.47 | 11.37 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.573
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.087
- estimate Comment
- Log-rank test stratified by: * Region (Asia vs Non-Asia) * Number of organs with metastatic sites (0 to 2 vs ≥ 3) * Prior gastrectomy (Yes or No)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0721
- param Type
- Hazard Ratio (HR)
- param Value
- 0.789
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.573
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.087
- estimate Comment
- Log-rank test stratified by: * Region (Asia vs Non-Asia) * Number of organs with metastatic sites (0 to 2 vs ≥ 3) * Prior gastrectomy (Yes or No)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0721
- param Type
- Hazard Ratio (HR)
- param Value
- 0.789
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.49
- upper Limit
- 10.38
- value
- 9.00
- group Id
- OG001
- lower Limit
- 6.47
- upper Limit
- 11.37
- value
- 8.11
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 134
- units
- Participants
- description
- DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.PD was defined as development of new, or progression of existing metastases to the primary cancer under the sudy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
- id
- OG000
- title
- mFOLFOX6 + Zolbetuximab
- description
- Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.
- id
- OG001
- title
- mFOLFOX6+ Placebo
- param Type
- MEDIAN
- population Description
- FAS - All Objective Responders
- reporting Status
- POSTED
- time Frame
- From date of first response (CR/PR) until 62 months and 18 day
- title
- Duration Of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice