TriangleNCT01688999 · STUDY IN CONTEXT
Cabozantinib for Advanced Urothelial Cancer
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
Measure the timing from the study start until death.
Measure the timing of maintaining stable disease or partial response until disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest um diameters while on study.
Grade 4 toxicity hypomagnesium experienced by participants related to Cabozantinib. Grade 4 toxicity is life-threatening consequences; urgent intervention indicated.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- trial label
- Cabozantinib for Advanced Urothelial Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0000
- source section id
- NCT01688999-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Overall Response
- endpoint definition
- 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.
- time origin
- Median follow-up was 61.2 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0001
- source section id
- NCT01688999-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Measure the timing from the study start until death.
- time origin
- Median follow-up was 61.2 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0002
- source section id
- NCT01688999-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival
- endpoint definition
- Measure the timing of maintaining stable disease or partial response until disease progression assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest um diameters while on study.
- time origin
- Median follow-up was 61.2 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 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.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0003
- source section id
- NCT01688999-om-0003
- source outcome index
- 3
- endpoint
- Number of Participants With Grade 4 Toxicity Hypomagnesium Related to Cabozantinib
- endpoint definition
- Grade 4 toxicity hypomagnesium experienced by participants related to Cabozantinib. Grade 4 toxicity is life-threatening consequences; urgent intervention indicated.
- time origin
- Median follow-up was 61.2 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- We did not group the adverse events by cohort because we did not expect the cohorts to experience different adverse events as they were all getting the same medication at the same dose. And 68/69 participants were analyzed because one participant was enrolled and deemed ineligible prior to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0004
- source section id
- NCT01688999-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Serious and Non-serious Adverse Events Regardless of Attribution
- endpoint definition
- Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
- time origin
- Median follow-up was 61.2 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- We did not group the adverse events by cohort because we did not expect the cohorts to experience different adverse events as they were all getting the same medication at the same dose. And 68/69 participants were analyzed because one participant was enrolled and deemed ineligible prior to treatment.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort 1 - (Urothelial Progressive Disease)
- regimen
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort 2 (Bone-only)
- regimen
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 3 (Rare Histologies)
- regimen
- Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort 1 - (Urothelial Progressive Disease)
- regimen
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort 2 (Bone-only)
- regimen
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort 3 (Rare Histologies)
- regimen
- Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cohort 1 - (Urothelial Progressive Disease)
- regimen
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cohort 2 (Bone-only)
- regimen
- Patients with bone-only urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 5
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Cohort 3 (Rare Histologies)
- regimen
- Patients with non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Participants
- regimen
- 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.
- analyzed count
- 68
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Participants
- regimen
- 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.
- analyzed count
- 68
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01688999-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-urothelial-carcinoma-keytruda-d5a86101
- nct id
- NCT01688999
- harm key
- EG000
- source section id
- NCT01688999-ae
- event group key
- EG000
- event group label
- All Participants
- serious affected
- 66
- serious at risk
- 68
- other affected
- 67
- other at risk
- 68
- frequency threshold
- 0
- collection period
- Median follow-up was 61.2 months
- event definition
- All serious and non-serious adverse events are reported regardless of attribution. We did not group the adverse events by cohort because we did not expect the cohorts to experience different adverse events as they were all getting the same medication at the same dose. And 68/69 participants were analyzed because one participant was enrolled and deemed ineligible prior to treatment.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice