Trial Outcomes & Findings for Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer (NCT NCT00849186)
NCT ID: NCT00849186
Last Updated: 2015-02-06
Results Overview
Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
90 days
Results posted on
2015-02-06
Participant Flow
Participant milestones
| Measure |
Sunitinib Malate (Sunitinib)
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Sunitinib Malate (Sunitinib)
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
not treated
|
6
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib Malate (Sunitinib)
n=20 Participants
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Age, Continuous
|
60.24 years
STANDARD_DEVIATION 9.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: All treated and eligible patients
Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
Outcome measures
| Measure |
Sunitinib Malate (Sunitinib)
n=20 Participants
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Safety of Sunitinib Malate (SM)
|
.350 proportion of participants
Interval 0.1812 to 0.5671
|
PRIMARY outcome
Timeframe: 90 daysPopulation: All treated and eligible patients
Incident Rate: Intraoperative Complication Rate
Outcome measures
| Measure |
Sunitinib Malate (Sunitinib)
n=20 Participants
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Safety of Surgery After 90 Days of Treatment With SM
|
.150 proportion of participants
Interval 0.0524 to 0.3604
|
SECONDARY outcome
Timeframe: 90 daysPopulation: All treated and eligible patients
Outcome measures
| Measure |
Sunitinib Malate (Sunitinib)
n=20 Participants
sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Response Rate After 90 Days of Treatment With SM
|
.20 proportion of participants
Interval 0.0807 to 0.416
|
Adverse Events
Sunitinib
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sunitinib
n=20 participants at risk
sunitinib malate: oral
neoadjuvant therapy: IV
therapeutic conventional surgery: Surgery
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.0%
7/20 • Number of events 7
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
4/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
8/20 • Number of events 8
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • Number of events 1
|
|
Eye disorders
Vision blurred
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
6/20 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
30.0%
6/20 • Number of events 6
|
|
Gastrointestinal disorders
Flatulence
|
20.0%
4/20 • Number of events 4
|
|
Gastrointestinal disorders
Gingival pain
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Number of events 8
|
|
Gastrointestinal disorders
Oral discomfort
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Paraesthesia oral
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Number of events 5
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Chest pain
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
60.0%
12/20 • Number of events 13
|
|
General disorders
Influenza like illness
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
10.0%
2/20 • Number of events 2
|
|
Injury, poisoning and procedural complications
Depression postoperative
|
5.0%
1/20 • Number of events 1
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
8/20 • Number of events 8
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood amylase
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood amylase increased
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Blood creatinine
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood creatinine decreased
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Lipase
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Lipase increased
|
30.0%
6/20 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.0%
3/20 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
2/20 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Number of events 4
|
|
Nervous system disorders
Hypogeusia
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1
|
|
Renal and urinary disorders
Urinary hesitation
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
20.0%
4/20 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
5.0%
1/20 • Number of events 1
|
|
Vascular disorders
Hypertension
|
25.0%
5/20 • Number of events 5
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place