TriangleNCT01248949 · OUTCOME
Time to Response (TTR)
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
Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated 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 | 2.6 | Not reported | 2.6 | 2.6 | Not reported |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 1.2 | Not reported | 1.2 | 1.2 | Not reported |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 2.0 | Not reported | 1.6 | 2.3 | Not reported |
| MEDI3617 + PACLITAXEL TOTAL | 1.7 | Not reported | 1.6 | 1.7 | Not reported |
| 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
- 2.6
- upper Limit
- 2.6
- value
- 2.6
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 1.2
- value
- 1.2
- group Id
- OG002
- lower Limit
- 1.6
- upper Limit
- 2.3
- value
- 2.0
- group Id
- OG003
- lower Limit
- 1.6
- upper Limit
- 1.7
- value
- 1.7
- 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
- Time to response (TTR) is defined as the time from the study entry to the first documentation of confirmed CR or confirmed PR. CR was defined as disappearance of all target lesions, any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (the sum may not be "0" if there are target nodes). PR was defined as at least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the TTR taken as the first time the response was observed, not the confirmation assessment. TTR was evaluated 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
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice