Trial Outcomes & Findings for Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy (NCT NCT01042795)

Last Updated: 2017-06-28

Results Overview

2-year disease free survival

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

2- year

Results posted on

2017-06-28

Participant milestones
Measure	Continuous Daily Dosing of Sunitinib Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Dosing Period - 16 Weeks of Daily Doses STARTED	7
Dosing Period - 16 Weeks of Daily Doses COMPLETED	2
Dosing Period - 16 Weeks of Daily Doses NOT COMPLETED	5
Follow up - 22 Months After Drug Start STARTED	2
Follow up - 22 Months After Drug Start COMPLETED	0
Follow up - 22 Months After Drug Start NOT COMPLETED	2

Withdrawal data not reported

Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy

Baseline characteristics by cohort
Measure	Continuous Daily Dosing of Sunitinib n=7 Participants Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Age, Customized 18-85 years	7 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

Timeframe: 2- year

2-year disease free survival

Outcome measures
Measure	Continuous Daily Dosing of Sunitinib n=7 Participants Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Disease Free Survival Patient 1 Time to Recurrence	4.7 months
Disease Free Survival Patient 2 Last Follow up. No Recurrence	21.1 months
Disease Free Survival Patient 3 Time to Recurrence	21.2 months
Disease Free Survival Patient 4 Last Follow up. No Recurrence	17.1 months
Disease Free Survival Patient 5 Last Follow up. No Recurrence	12.3 months
Disease Free Survival Patient 6 Time to Recurrence	12.2 months
Disease Free Survival Patient 7 Last Follow up. No Recurrence	9.4 months

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events
Measure	Continuous Daily Dosing of Sunitinib n=7 participants at risk Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Infections and infestations pyelonephritis	14.3% 1/7 • 21.5 months - after that point no one was still in the trial
Blood and lymphatic system disorders anemia	14.3% 1/7 • 21.5 months - after that point no one was still in the trial
Gastrointestinal disorders mucositis	14.3% 1/7 • 21.5 months - after that point no one was still in the trial

Other adverse events
Measure	Continuous Daily Dosing of Sunitinib n=7 participants at risk Sunitinib: Sunitinib 37.5 mg daily X 16 weeks
Blood and lymphatic system disorders neutropenia	85.7% 6/7 • 21.5 months - after that point no one was still in the trial
Gastrointestinal disorders diarrhea	71.4% 5/7 • 21.5 months - after that point no one was still in the trial
Gastrointestinal disorders nausea	71.4% 5/7 • 21.5 months - after that point no one was still in the trial
General disorders fatigue	42.9% 3/7 • 21.5 months - after that point no one was still in the trial
Vascular disorders hypertension	42.9% 3/7 • 21.5 months - after that point no one was still in the trial
Blood and lymphatic system disorders thrombocytopenia	42.9% 3/7 • 21.5 months - after that point no one was still in the trial
Cardiac disorders cardiac dysfunction	14.3% 1/7 • 21.5 months - after that point no one was still in the trial

University of Michigan

Phone: 614-685-6666