TriangleNCT02664961 · OUTCOME
Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 8 weeks
What was measured
Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed via RECIST 1.1 and by measuring circulating bHCG. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.
Analysis population: All patients who had a baseline scan and at least 1 on study assessment
Groups in this outcome
TRC105 and/or Bevacizumab
All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks. TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing. Bevacizumab: Bevacizumab will be dosed every two weeks.
| Group | Source count |
|---|---|
| TRC105 and/or Bevacizumab | 3 |
Reported measurements
Number of patients with best response of PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TRC105 and/or Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
Number of patients with best response of SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TRC105 and/or Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
Number of patients with best response of PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TRC105 and/or Bevacizumab | 3 | Not reported | Not reported | Not reported | Not reported |
Number of patients with best response of CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TRC105 and/or Bevacizumab | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Number of patients with best response of PR
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Number of patients with best response of SD
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Number of patients with best response of PD
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Number of patients with best response of CR
- denoms
- counts
- group Id
- OG000
- value
- 3
- units
- Participants
- description
- Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed via RECIST 1.1 and by measuring circulating bHCG. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.
- groups
- description
- All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks. TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing. Bevacizumab: Bevacizumab will be dosed every two weeks.
- id
- OG000
- title
- TRC105 and/or Bevacizumab
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients who had a baseline scan and at least 1 on study assessment
- reporting Status
- POSTED
- time Frame
- 8 weeks
- title
- Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice