Trial Outcomes & Findings for Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium (NCT NCT00397488)

Last Updated: 2016-01-25

Results Overview

Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib Sunitinib in patients with metastatic urothelial carcinoma.
Overall Study STARTED	78
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Sunitinib in patients with metastatic urothelial carcinoma.
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	3
Overall Study Death	1

Baseline Characteristics

Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=78 Participants Sunitinib in patients with metastatic urothelial carcinoma.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=99 Participants
Age, Categorical >=65 years	39 Participants n=99 Participants
Sex: Female, Male Female	24 Participants n=99 Participants
Sex: Female, Male Male	54 Participants n=99 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Sunitinib n=71 Participants Sunitinib in patients with metastatic urothelial carcinoma.
Overall Objective Response Partial Response (PR)	3 participants
Overall Objective Response Stable Disease (SD)	29 participants
Overall Objective Response Progression of Disease (POD)	39 participants

Adverse Events

Sunitinib

Serious events: 34 serious events

Other events: 67 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib n=78 participants at risk Sunitinib in patients with metastatic urothelial carcinoma.
Cardiac disorders Cardiac ischemia/infarction	1.3% 1/78 • Number of events 1
Gastrointestinal disorders Constipation	1.3% 1/78 • Number of events 1
Metabolism and nutrition disorders Creatinine	1.3% 1/78 • Number of events 1
General disorders Death not associated with CTCAE term- Death NOS	5.1% 4/78 • Number of events 4
General disorders Death not associated with CTCAE term-Disease progression	2.6% 2/78 • Number of events 2
General disorders Dehydration	2.6% 2/78 • Number of events 2
Gastrointestinal disorders Distension/bloating, abdominal	1.3% 1/78 • Number of events 1
General disorders Extremity-lower (gait/walking)	1.3% 1/78 • Number of events 1
General disorders Fatigue (asthenia, lethargy, malaise)	2.6% 2/78 • Number of events 2
General disorders Fever (in the absence of neutropenia)	1.3% 1/78 • Number of events 1
Gastrointestinal disorders Fistula, GI- Small bowel	1.3% 1/78 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	1.3% 1/78 • Number of events 1
Cardiac disorders Hypertension	1.3% 1/78 • Number of events 1
Renal and urinary disorders Bladder infection	2.6% 2/78 • Number of events 2
General disorders Sepsis	1.3% 1/78 • Number of events 1
General disorders Pneumonia	1.3% 1/78 • Number of events 1
Infections and infestations Infection	5.1% 4/78 • Number of events 4
Nervous system disorders Memory impairment	1.3% 1/78 • Number of events 1
Gastrointestinal disorders Nausea	1.3% 1/78 • Number of events 1
Gastrointestinal disorders Small intestinal obstruction	2.6% 2/78 • Number of events 2
Gastrointestinal disorders Abdominal pain	6.4% 5/78 • Number of events 5
General disorders Pain - Back	3.8% 3/78 • Number of events 3
General disorders Pain - Bone	1.3% 1/78 • Number of events 1
General disorders Pain - Extremity-limb	2.6% 2/78 • Number of events 2
General disorders Pain - Head/headache	2.6% 2/78 • Number of events 2
General disorders Pain - Pelvis	1.3% 1/78 • Number of events 1
Blood and lymphatic system disorders Platelets	1.3% 1/78 • Number of events 1
Renal and urinary disorders Renal failure	2.6% 2/78 • Number of events 2
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	2.6% 2/78 • Number of events 2
Renal and urinary disorders Urinary retention	2.6% 2/78 • Number of events 2

Other adverse events

Other adverse events
Measure	Sunitinib n=78 participants at risk Sunitinib in patients with metastatic urothelial carcinoma.
Metabolism and nutrition disorders Albumin, low (hypoalbuminemia)	7.7% 6/78 • Number of events 6
Metabolism and nutrition disorders Alkaline phosphatase	10.3% 8/78 • Number of events 8
Blood and lymphatic system disorders ALT, SGPT	6.4% 5/78 • Number of events 5
General disorders Anorexia	5.1% 4/78 • Number of events 4
Blood and lymphatic system disorders AST, SGOT	7.7% 6/78 • Number of events 6
Metabolism and nutrition disorders Creatinine	16.7% 13/78 • Number of events 13
Gastrointestinal disorders Diarrhea	5.1% 4/78 • Number of events 4
General disorders Fatigue (asthenia, lethargy, malaise)	35.9% 28/78 • Number of events 28
Metabolism and nutrition disorders Glucose, high (hyperglycemia)	23.1% 18/78 • Number of events 18
Gastrointestinal disorders Heartburn/dyspepsia	6.4% 5/78 • Number of events 5
Blood and lymphatic system disorders Hemoglobin	35.9% 28/78 • Number of events 28
Renal and urinary disorders Hemorrhage, Urinary NOS	6.4% 5/78 • Number of events 5
Cardiac disorders Hypertension	7.7% 6/78 • Number of events 6
Blood and lymphatic system disorders Leukocytes (total WBC)	37.2% 29/78 • Number of events 29
Blood and lymphatic system disorders Lymphopenia	24.4% 19/78 • Number of events 19
Gastrointestinal disorders Nausea	9.0% 7/78 • Number of events 7
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	25.6% 20/78 • Number of events 20
Metabolism and nutrition disorders Phosphate, low (hypophosphatemia)	9.0% 7/78 • Number of events 7
Blood and lymphatic system disorders Platelets	25.6% 20/78 • Number of events 20
Metabolism and nutrition disorders Potassium, high (hyperkalemia)	6.4% 5/78 • Number of events 5
Blood and lymphatic system disorders Partial thromboplastin time (PTT)	6.4% 5/78 • Number of events 5
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	16.7% 13/78 • Number of events 13
Metabolism and nutrition disorders Sodium, low (hyponatremia)	6.4% 5/78 • Number of events 5
General disorders Weight loss	5.1% 4/78 • Number of events 4

Additional Information

Dr. Dean Bajorin

Memorial Sloan Kettering Cancer Center

Phone: 646-422-4333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place