TriangleNCT03329690 · OUTCOME
Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
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 the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose
What was measured
Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Analysis population: Progression-free survival (PFS) was assessed in the Intent-to-Treat Analysis Set.
Groups in this outcome
DS-8201a
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
Physician's Choice Irinotecan
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
Physician's Choice Paclitaxel
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
Physician's Choice Overall
Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
Exploratory: Naïve HER2 IHC 1+, DS-8201a
Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
| Group | Source count |
|---|---|
| DS-8201a | 126 |
| Physician's Choice Irinotecan | 55 |
| Physician's Choice Paclitaxel | 7 |
| Physician's Choice Overall | 62 |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | 21 |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | 22 |
Reported measurements
PFS, 25 months (DCO: Nov 8, 2019)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DS-8201a | 5.6 | Not reported | 4.3 | 6.9 | Not reported |
| Physician's Choice Irinotecan | 2.8 | Not reported | 2.0 | 4.3 | Not reported |
| Physician's Choice Paclitaxel | 4.9 | Not reported | 2.0 | NA | Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity. |
| Physician's Choice Overall | 3.5 | Not reported | 2.0 | 4.3 | Not reported |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | 4.4 | Not reported | 2.7 | 7.1 | Not reported |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | 2.8 | Not reported | 1.5 | 4.3 | Not reported |
PFS, 36 months (DCO: Dec 11, 2020)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DS-8201a | 5.6 | Not reported | 4.3 | 6.9 | Not reported |
| Physician's Choice Irinotecan | 2.8 | Not reported | 2.0 | 4.3 | Not reported |
| Physician's Choice Paclitaxel | 4.9 | Not reported | 2.0 | NA | Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity. |
| Physician's Choice Overall | 3.5 | Not reported | 2.0 | 4.3 | Not reported |
| Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a | 4.4 | Not reported | 2.7 | 7.1 | Not reported |
| Exploratory: Naïve HER2 IHC 1+, DS-8201a | 2.8 | Not reported | 1.5 | 4.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 6.9
- value
- 5.6
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 4.3
- value
- 2.8
- comment
- Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.
- group Id
- OG002
- lower Limit
- 2.0
- upper Limit
- NA
- value
- 4.9
- group Id
- OG003
- lower Limit
- 2.0
- upper Limit
- 4.3
- value
- 3.5
- group Id
- OG004
- lower Limit
- 2.7
- upper Limit
- 7.1
- value
- 4.4
- group Id
- OG005
- lower Limit
- 1.5
- upper Limit
- 4.3
- value
- 2.8
- title
- PFS, 25 months (DCO: Nov 8, 2019)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 6.9
- value
- 5.6
- group Id
- OG001
- lower Limit
- 2.0
- upper Limit
- 4.3
- value
- 2.8
- comment
- Missing upper limit was not calculable due to right censored data; last timepoint censored and estimate is infinity.
- group Id
- OG002
- lower Limit
- 2.0
- upper Limit
- NA
- value
- 4.9
- group Id
- OG003
- lower Limit
- 2.0
- upper Limit
- 4.3
- value
- 3.5
- group Id
- OG004
- lower Limit
- 2.7
- upper Limit
- 7.1
- value
- 4.4
- group Id
- OG005
- lower Limit
- 1.5
- upper Limit
- 4.3
- value
- 2.8
- title
- PFS, 36 months (DCO: Dec 11, 2020)
- denoms
- counts
- group Id
- OG000
- value
- 126
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 62
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 22
- units
- Participants
- description
- Progression-free survival (PFS) was defined as the time from the date of randomization (the date of the registration for the Exploratory Cohorts) to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
- id
- OG000
- title
- DS-8201a
- description
- Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
- id
- OG001
- title
- Physician's Choice Irinotecan
- description
- Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
- id
- OG002
- title
- Physician's Choice Paclitaxel
- description
- Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
- id
- OG003
- title
- Physician's Choice Overall
- description
- Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
- id
- OG004
- title
- Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
- description
- Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
- id
- OG005
- title
- Exploratory: Naïve HER2 IHC 1+, DS-8201a
- param Type
- MEDIAN
- population Description
- Progression-free survival (PFS) was assessed in the Intent-to-Treat Analysis Set.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the first documented disease progression or date of death (whichever occurs first), up to 36 months postdose
- title
- Progression-Free Survival Based on Independent Central Review Following Treatment With DS-8201a in Participants With HER2-Expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (Intent-to-Treat Analysis Set)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice