TriangleNCT01587703 · OUTCOME
Overall Response Rate-Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Median of 1.41 months of drug exposure
What was measured
Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Analysis population: All Treated Population
Groups in this outcome
Participants With NMC
Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With SCLC
Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With CRPC
Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With TNBC
Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With ER+BC
Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
Participants With GIST
Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
| Group | Source count |
|---|---|
| Participants With NMC | 12 |
| Participants With SCLC | 14 |
| Participants With CRPC | 23 |
| Participants With TNBC | 19 |
| Participants With ER+BC | 21 |
| Participants With GIST | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Participants With NMC | 8 | Not reported | 0.2 | 38.5 | Not reported |
| Participants With SCLC | 0 | Not reported | 0.0 | 23.2 | Not reported |
| Participants With CRPC | 4 | Not reported | 0.1 | 21.9 | Not reported |
| Participants With TNBC | 0 | Not reported | 0.0 | 17.6 | Not reported |
| Participants With ER+BC | 0 | Not reported | 0.0 | 16.1 | Not reported |
| Participants With GIST | 0 | Not reported | 0.0 | 24.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 38.5
- value
- 8
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 23.2
- value
- 0
- group Id
- OG002
- lower Limit
- 0.1
- upper Limit
- 21.9
- value
- 4
- group Id
- OG003
- lower Limit
- 0.0
- upper Limit
- 17.6
- value
- 0
- group Id
- OG004
- lower Limit
- 0.0
- upper Limit
- 16.1
- value
- 0
- group Id
- OG005
- lower Limit
- 0.0
- upper Limit
- 24.7
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 21
- group Id
- OG005
- value
- 13
- units
- Participants
- description
- Overall response rate is defined as the percentage of participants who achieved a confirmed CR or PR from the start of treatment until disease progression or the start of new anticancer therapy, among participants who received at least 1 dose of treatment. Overall response rate was determined by the investigator according to RECIST v 1.1. CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG000
- title
- Participants With NMC
- description
- Participants with small cell lung cancer(SCLC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG001
- title
- Participants With SCLC
- description
- Participants with Castrate-Resistant Prostate Cancer (CRPC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG002
- title
- Participants With CRPC
- description
- Participants with Triple Negative Breast Cancer (TNBC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG003
- title
- Participants With TNBC
- description
- Participants with estrogen receptor positive breast cancer (ER+BC) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG004
- title
- Participants With ER+BC
- description
- Participants with Gastrointestinal Stromal Tumor (GIST) were administered continuous once daily oral dose of 75 mg GSK525762
- id
- OG005
- title
- Participants With GIST
- param Type
- NUMBER
- population Description
- All Treated Population
- reporting Status
- POSTED
- time Frame
- Median of 1.41 months of drug exposure
- title
- Overall Response Rate-Part 2
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice