TriangleNCT01248949 · OUTCOME
Time to Progression (TTP)
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 progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP 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 | 1.4 | Not reported | 0.0 | 8.6 | Not reported |
| MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL | 11.4 | Not reported | 0.0 | 39.4 | Not reported |
| MEDI3617 + BEVACIZUMAB Q2W TOTAL | 1.8 | Not reported | 0.0 | 5.3 | Not reported |
| MEDI3617 + PACLITAXEL TOTAL | 3.5 | Not reported | 0.0 | 19.4 | Not reported |
| MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL | NA | Not reported | 0.0 | 4.0 | Due to the lack of available data caused by censoring subjects in the MEDI3617 + carboplatin/paclitaxel cohorts for this endpoint, median time to progression was not calculable. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 8.6
- value
- 1.4
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 39.4
- value
- 11.4
- group Id
- OG002
- lower Limit
- 0.0
- upper Limit
- 5.3
- value
- 1.8
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 19.4
- value
- 3.5
- comment
- Due to the lack of available data caused by censoring subjects in the MEDI3617 + carboplatin/paclitaxel cohorts for this endpoint, median time to progression was not calculable.
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 4.0
- 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 progression (TTP) is defined as time from the start of treatment with MEDI3617 until the documentation of disease progression. The TTP was censored on the date of last tumor assessment documenting absence of tumor progression for participants who have no documented progression prior to data cutoff, dropout, or the initiation of alternate anticancer treatment. Participants having no tumor assessments after the start of treatment with MEDI3617 had TTP censored on the first date of treatment with MEDI3617. TTP 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 Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice