TriangleNCT01010126 · OUTCOME
Tumor Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 3 years
What was measured
Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to \<1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort.
Analysis population: For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response.
Groups in this outcome
Endometrial Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ovarian Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Hepatocellular Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Carcinoid Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Islet Cell (Double Agent) Cohort
Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Islet Cell (Bevacizumab-only) Cohort
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Endometrial Cohort | 26 |
| Ovarian Cohort | 58 |
| Hepatocellular Cohort | 27 |
| Carcinoid Cohort | 57 |
| Islet Cell (Double Agent) Cohort | 58 |
| Islet Cell (Bevacizumab-only) Cohort | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cohort | 0.31 | Not reported | 0.14 | 0.52 | Not reported |
| Ovarian Cohort | 0.31 | Not reported | 0.20 | 0.45 | Not reported |
| Hepatocellular Cohort | 0.19 | Not reported | 0.06 | 0.38 | Not reported |
| Carcinoid Cohort | 0.12 | Not reported | 0.05 | 0.24 | Not reported |
| Islet Cell (Double Agent) Cohort | 0.40 | Not reported | 0.27 | 0.53 | Not reported |
| Islet Cell (Bevacizumab-only) Cohort | 0.17 | Not reported | 0.05 | 0.37 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.14
- upper Limit
- 0.52
- value
- 0.31
- group Id
- OG001
- lower Limit
- 0.20
- upper Limit
- 0.45
- value
- 0.31
- group Id
- OG002
- lower Limit
- 0.06
- upper Limit
- 0.38
- value
- 0.19
- group Id
- OG003
- lower Limit
- 0.05
- upper Limit
- 0.24
- value
- 0.12
- group Id
- OG004
- lower Limit
- 0.27
- upper Limit
- 0.53
- value
- 0.40
- group Id
- OG005
- lower Limit
- 0.05
- upper Limit
- 0.37
- value
- 0.17
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 57
- group Id
- OG004
- value
- 58
- group Id
- OG005
- value
- 24
- units
- Participants
- description
- Tumor response rate defined as the total number of efficacy-evaluable patients who achieved a complete or partial response according to the RECIST criteria divided by the total number of efficacy evaluable patients enrolled on study. Patients were evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. In brief, a Complete Response (CR) means the complete disappearance of all target lesions and a reduction in each lymph node to \<1 cm. A Partial Response (PR) is defined as a 30% decrease in the sum of the longest diameter of the non-nodal target lesion from baseline. Each requires no new lesions present at evaluation. The proportion of participants with a response is provided here for each cohort. The proportion was calculated as the number of patients that had a best response of CR or PR divided by the number of patients evaluated for a response in each cohort.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Endometrial Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Ovarian Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- Hepatocellular Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- Carcinoid Cohort
- description
- Patients receive 25 mg temsirolimus IV on days 1, 8, 15, and 22, and 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- Islet Cell (Double Agent) Cohort
- description
- Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- id
- OG005
- title
- Islet Cell (Bevacizumab-only) Cohort
- param Type
- NUMBER
- population Description
- For this analysis, the number of patients that had a best response of CR or PR were divided by the number of patients evaluated for a response.
- reporting Status
- POSTED
- time Frame
- Up to 3 years
- title
- Tumor Response Rate
- type
- PRIMARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice