TriangleNCT01688999 · OUTCOME
Percentage of Participants With Overall Response
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 follow-up was 61.2 months
What was measured
Complete Response (CR) or Partial Response (PR) to Cabozantinib (XL184) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: 42/50 were analyzed in cohort 1 because 5 participants withdrew, 2 were taken off study for adverse events and 1 was ineligible. In cohort 2, 5/6 patients were analyzed because 1 withdrew; and in cohort 3, 10/13 patients were analyzed because 1 withdrew and 2 were taken off study due to adverse events.
Groups in this outcome
Cohort 1 - (Urothelial Progressive Disease)
Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
Cohort 2 (Bone-only)
Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
Cohort 3 (Rare Histologies)
Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
| Group | Source count |
|---|---|
| Cohort 1 - (Urothelial Progressive Disease) | 42 |
| Cohort 2 (Bone-only) | 5 |
| Cohort 3 (Rare Histologies) | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 - (Urothelial Progressive Disease) | 19.1 | Not reported | 8.6 | 34.1 | Not reported |
| Cohort 2 (Bone-only) | NA | Not reported | NA | NA | The percentage and 95% CI cannot be calculated for this cohort because the participants had no measurable disease. |
| Cohort 3 (Rare Histologies) | NA | Not reported | NA | NA | The percentage and 95% CI cannot be calculated for this cohort because the participants had no measurable disease. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.6
- upper Limit
- 34.1
- value
- 19.1
- comment
- The percentage and 95% CI cannot be calculated for this cohort because the participants had no measurable disease.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The percentage and 95% CI cannot be calculated for this cohort because the participants had no measurable disease.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Complete Response (CR) or Partial Response (PR) to Cabozantinib (XL184) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- id
- OG000
- title
- Cohort 1 - (Urothelial Progressive Disease)
- description
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- id
- OG001
- title
- Cohort 2 (Bone-only)
- description
- Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
- id
- OG002
- title
- Cohort 3 (Rare Histologies)
- param Type
- NUMBER
- population Description
- 42/50 were analyzed in cohort 1 because 5 participants withdrew, 2 were taken off study for adverse events and 1 was ineligible. In cohort 2, 5/6 patients were analyzed because 1 withdrew; and in cohort 3, 10/13 patients were analyzed because 1 withdrew and 2 were taken off study due to adverse events.
- reporting Status
- POSTED
- time Frame
- Median follow-up was 61.2 months
- title
- Percentage of Participants With Overall Response
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice