TriangleNCT01248949 · 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
- Full Range
- Time frame
- Time from the first dose of investigational product until end of study
What was measured
Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.
Analysis population: Safety population included all participants who received treatment with MEDI3617.
Groups in this outcome
MEDI3617 SINGLE AGENT TOTAL
Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
MEDI3617 + BEVACIZUMAB Q2W TOTAL
Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + PACLITAXEL TOTAL
Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
| Group | Source count |
|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 42 |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 16 |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 38 |
| MEDI3617 + PACLITAXEL TOTAL | 13 |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEDI3617 SINGLE AGENT TOTAL | 3.7 | Not reported | 3.7 | 3.7 | Not reported |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | NA | Not reported | 17.8 | 17.8 | Due to the lack of available data caused by censoring subjects in the MEDI3617 + bevacizumab Q3W escalation cohorts for this endpoint, median duration of response was not calculable. |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | NA | Not reported | 2.9 | 3.7 | Due to the lack of available data caused by censoring subjects in the MEDI3617 + bevacizumab Q2W cohorts for this endpoint, median duration of response was not calculable. |
| MEDI3617 + PACLITAXEL TOTAL | NA | Not reported | 1.6 | 17.7 | Due to the lack of available data caused by censoring subjects in the MEDI3617 + paclitaxel cohorts for this endpoint, median duration of response was not calculable. |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | NA | Not reported | NA | NA | No objective response was observed in the MEDI3617 + carboplatin/paclitaxel cohorts. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.7
- upper Limit
- 3.7
- value
- 3.7
- comment
- Due to the lack of available data caused by censoring subjects in the MEDI3617 + bevacizumab Q3W escalation cohorts for this endpoint, median duration of response was not calculable.
- group Id
- OG001
- lower Limit
- 17.8
- upper Limit
- 17.8
- value
- NA
- comment
- Due to the lack of available data caused by censoring subjects in the MEDI3617 + bevacizumab Q2W cohorts for this endpoint, median duration of response was not calculable.
- group Id
- OG002
- lower Limit
- 2.9
- upper Limit
- 3.7
- value
- NA
- comment
- Due to the lack of available data caused by censoring subjects in the MEDI3617 + paclitaxel cohorts for this endpoint, median duration of response was not calculable.
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- 17.7
- value
- NA
- comment
- No objective response was observed in the MEDI3617 + carboplatin/paclitaxel cohorts.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 7
- units
- Participants
- description
- Duration of response is defined as the duration from the first documentation of objective disease response (ie, confirmed CR or confirmed PR) to the first documented disease progression. The duration of response was censored on the date of last tumor assessment documenting absence of disease progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Duration of response was evaluated for the subgroup of participants with an objective response using the Kaplan-Meier method.
- dispersion Type
- Full Range
- groups
- description
- Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG000
- title
- MEDI3617 SINGLE AGENT TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG001
- title
- MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL
- description
- Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG002
- title
- MEDI3617 + BEVACIZUMAB Q2W TOTAL
- description
- Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
- id
- OG003
- title
- MEDI3617 + PACLITAXEL TOTAL
- description
- Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
- id
- OG004
- title
- MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL
- param Type
- MEDIAN
- population Description
- Safety population included all participants who received treatment with MEDI3617.
- reporting Status
- POSTED
- time Frame
- Time from the first dose of investigational product until end of study
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice