TriangleNCT01010126 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years
What was measured
Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.
Analysis population: All patients that were assessed as a Complete Response or Partial Response were included in this analysis.
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 | 8 |
| Ovarian Cohort | 18 |
| Hepatocellular Cohort | 5 |
| Carcinoid Cohort | 7 |
| Islet Cell (Double Agent) Cohort | 23 |
| Islet Cell (Bevacizumab-only) Cohort | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Endometrial Cohort | 25.1 | Not reported | 0 | 35.5 | Not reported |
| Ovarian Cohort | 6.4 | Not reported | 3.7 | 10.8 | Not reported |
| Hepatocellular Cohort | 6.4 | Not reported | 0 | 11.1 | Not reported |
| Carcinoid Cohort | 15.0 | Not reported | 0 | 18.8 | Not reported |
| Islet Cell (Double Agent) Cohort | 11.3 | Not reported | 8.8 | 21.2 | Not reported |
| Islet Cell (Bevacizumab-only) Cohort | 10.9 | Not reported | 3.7 | 34.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 35.5
- value
- 25.1
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 10.8
- value
- 6.4
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 11.1
- value
- 6.4
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 18.8
- value
- 15.0
- group Id
- OG004
- lower Limit
- 8.8
- upper Limit
- 21.2
- value
- 11.3
- group Id
- OG005
- lower Limit
- 3.7
- upper Limit
- 34.1
- value
- 10.9
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 23
- group Id
- OG005
- value
- 4
- units
- Participants
- description
- Duration of response is defined for all evaluable patients who have achieved a response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Objective response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) as described in Primary Objective 2 in this report. Median duration of response and the confidence interval for the median duration will be computed.
- 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
- MEDIAN
- population Description
- All patients that were assessed as a Complete Response or Partial Response were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Time from date at which the patient's objective status is first noted to be either a complete response (CR) or partial response (PR) to the date progression is documented, assessed up to 3 years
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice