NCT04513665 · OUTCOME
Overall Response Rate/ORR of Participants
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
- </= 24 weeks from the start of treatment
What was measured
ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment
Analysis population: No participants accrued to Stage 2 arm
Groups in this outcome
Stage 1
Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
Stage 2
If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
| Group | Source count |
|---|---|
| Stage 1 | 16 |
| Stage 2 | 0 |
Reported measurements
Source class 1
Participants with ORR (CR + PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage 1 | 1 | Not reported | Not reported | Not reported | Not reported |
Participants without ORR (CR + PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage 1 | 15 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Participants with ORR (CR + PR)
- measurements
- group Id
- OG000
- value
- 15
- title
- Participants without ORR (CR + PR)
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- ORR = Compete Response (CR) + Partial Response (PR) by RECIST v 1.1 \</= 24 weeks from the start of treatment
- groups
- description
- Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. 16 participants will be accrued. If 2 or greater responses are seen, Stage 2 will accrue additional participants. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
- id
- OG000
- title
- Stage 1
- description
- If 2 or greater responses are seen during Stage 1, Stage 2 will accrue an additional 9 participants. Participants will have recurrent endometrial carcinoma or carcinosarcoma with HER2 overexpression and 1-2 prior lines of chemotherapy. ZW25: ZW25 at 20mg/kg intravenously (IV) every two weeks.
- id
- OG001
- title
- Stage 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- No participants accrued to Stage 2 arm
- reporting Status
- POSTED
- time Frame
- </= 24 weeks from the start of treatment
- title
- Overall Response Rate/ORR of Participants
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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