Trial Outcomes & Findings for Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer (NCT NCT00137423)
NCT ID: NCT00137423
Last Updated: 2009-09-30
Results Overview
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
COMPLETED
PHASE2
107 participants
4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow up
2009-09-30
Participant Flow
Patients must have failed 1 prior cytokine-based therapy for metastatic renal cell carcinoma and had to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
ECOG performance status definition 0=fully active, able to carry on all pre-disease activities without restriction 1= restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature (eg light house work or office work)
Participant milestones
| Measure |
AM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, \& were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
|
PM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, \& were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
COMPLETED
|
15
|
9
|
|
Overall Study
NOT COMPLETED
|
39
|
44
|
Reasons for withdrawal
| Measure |
AM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, \& were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
|
PM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, \& were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
9
|
|
Overall Study
consent withdrawn
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
31
|
33
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Study Of SU011248 (Sunitinib) Given In A Continuous Daily Regimen In Patients With Advanced Renal Cell Cancer
Baseline characteristics by cohort
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, \& were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, \& were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.3 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
57.2 years
STANDARD_DEVIATION 11.48 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 10.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow upPopulation: ITT; CR,PR calculated from patients with measurable disease at baseline+correct histological cancer type+ refractory to prior cytokine-based therapy n= 53,52 (AM,PM)
Confirmed objective responses using RECIST criteria defined as responses persisting on repeat imaging study for 2 assessments with at least 4 weeks between, and evaluating all target and non-target sites followed since baseline. Two PRs separated by an SD or NE visit in between was considered a confirmed response if the 2 PRs were \> 4 weeks apart. CR=disappearance of all target lesions. PR is a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Objective Response (Complete Response[CR] + Partial Response[PR]) in Subjects
|
15 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow upPopulation: ITT; DR time from start of 1st documentation of objective tumor response to 1st documentation of objective tumor progression or death \& calculated for the subgroup of subjects with a confirmed objective tumor response. Descriptive statistics for responders who had an event. Total number responders n= 15,6(AM,PM). Response duration n=7,3(AM,PM).
Using RECIST criteria: date of 1st objective tumor response (CR or PR) subsequently confirmed to date of 1st objective tumor progression or to death due to any cause within 28 days after last dose of study medication, whichever was first. Censored on day after the date of the last oncologic assessment documenting no tumor progression.
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Duration of Tumor Response
|
24.0 weeks
Interval 16.1 to 64.1
|
32.0 weeks
Interval 16.1 to 32.1
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow upPopulation: ITT;TTP calculated based on subgroup with baseline disease assessment, measurable disease at baseline, correct histological type and refractory to cytokine.Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. n=53,52(AM,PM).
Time from date of first dose of study medication to date of first documentation of objective tumor progression using RECIST criteria that occurred on treatment including within 28 days after the last dose of study medication. TTP censored on the day following the date of last oncologic assessment documenting absence of tumor progression. TTP based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Time to Tumor Progression (TTP)
|
35.7 weeks
Interval 27.9 to 50.0
|
35.9 weeks
Interval 20.3 to 38.1
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow upPopulation: ITT; Calculation based on subgroup of patients with baseline disease assessment, measurable disease at baseline, correct histological type and are refractory to cytokine. Estimates based on Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley. N=53,52(AM,PM).
Using RECIST criteria: Time from date 1st dose study medication to date 1st documentation of objective tumor progression or death due to any cause occurring on treatment including within 28 days after last dose, whichever occurred 1st. Censored on day following the date of last oncologic assessment documenting absence of tumor progression. PFS based on the number of subjects with measurable disease at baseline, the correct histological cancer type, and had disease that was refractory to prior cytokine-based therapy(105 in total group).
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
35.7 weeks
Interval 27.6 to 50.0
|
35.3 weeks
Interval 20.3 to 38.1
|
SECONDARY outcome
Timeframe: 4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation includes 28 day post study follow upPopulation: ITT; Patients who are alive at the time of analysis or who are lost to follow up are censored on the last date they were known to be alive. Estimates are based on the Kaplan-Meier method with 95% CI calculated based on Brookmeyer and Crowley method. n=54,53(AM,PM).
Overall survival is time from the date of first dose of medication to the date of death due to any cause
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Overall Survival
|
91.4 weeks
Interval 69.4 to 115.4
|
76.4 weeks
Interval 59.6 to 108.3
|
SECONDARY outcome
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.Population: ITT; Results summarized by cohort \& time point through Cycle 13 (the last cycle for which more than 3 subjects completed the questionnaire on either arm). If more than 50% of the items in the scale were answered, then missing items were imputed with the mean of the non-missing items scored at that visit. Outcome based on completed questionnaires.
FACIT Fatigue Scale: Overall score from 13-questionnaire, which measures fatigue / asthenia for patients with chronic, life-threatening illnesses. For each question, a patient rates his / her condition for the past week on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Higher scores always represent less fatigue / asthenia. Outcome based on completed questionnaires.
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Summary of FACIT Fatigue Scale Overall Score
Baseline Score n=52,52
|
39.5 score on scale
Standard Deviation 11.41
|
39.6 score on scale
Standard Deviation 10.15
|
|
Summary of FACIT Fatigue Scale Overall Score
Maximum Post-Baseline Score n=53,52
|
43.4 score on scale
Standard Deviation 7.86
|
42.7 score on scale
Standard Deviation 8.19
|
|
Summary of FACIT Fatigue Scale Overall Score
Minimum Post-Baseline Score n=53,52
|
28.0 score on scale
Standard Deviation 12.34
|
29.4 score on scale
Standard Deviation 13.65
|
SECONDARY outcome
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.Population: ITT
EQ-5D health status in 5 dimensions (mobility, self-care, pain / discomfort, anxiety / depression, usual activities) with a weighted health index based on general population values where 0.0=death and 1.0 = perfect health. Change: median index score at observation minus median index score at baseline.
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index
Maximum Increase
|
0.0 score on scale
Interval -0.7 to 0.9
|
0.0 score on scale
Interval -0.3 to 1.0
|
|
Change From Baseline in Euro-QoL Five Dimension (EQ-5D) Weighted Health Index
Maximum Decrease
|
0.0 score on scale
Interval -0.8 to 0.8
|
-0.1 score on scale
Interval -0.6 to 0.7
|
SECONDARY outcome
Timeframe: Day 1 and day 15 of each treatment cycle from cycle 1 to cycle 4; day 1 of each treatment cycle after cycle 4 up to one year.Population: ITT
EQ-VAS score on the self-rated "thermometer" indicated the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state. Change: median score at observation minus median score at baseline. Maximum changes (increase or decrease from baseline).
Outcome measures
| Measure |
AM Dose Sunitinib Malate (SU011248)
n=54 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
n=53 Participants
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score
Maximum Increase
|
0.0 score on scale
Interval -40.0 to 32.0
|
0.0 score on scale
Interval -45.0 to 92.0
|
|
Change From Baseline in EuroQoL Visual Analog Scale (EQ-VAS) Overall Health Thermometer Score
Maximum Decrease
|
-10.0 score on scale
Interval -51.0 to 80.0
|
-9.0 score on scale
Interval -40.0 to 44.0
|
Adverse Events
AM Dose Sunitinib Malate (SU011248)
PM Dose Sunitinib Malate (SU011248)
Serious adverse events
| Measure |
AM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
3/54
|
1.9%
1/53
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/54
|
3.8%
2/53
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/54
|
1.9%
1/53
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/54
|
1.9%
1/53
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/54
|
0.00%
0/53
|
|
Eye disorders
Eye pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Abdominal pain
|
7.4%
4/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Haematemesis
|
1.9%
1/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
2/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Oesophagitis
|
1.9%
1/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Subileus
|
3.7%
2/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Melaena
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
1/54
|
0.00%
0/53
|
|
General disorders
Asthenia
|
1.9%
1/54
|
3.8%
2/53
|
|
General disorders
Disease progression
|
0.00%
0/54
|
5.7%
3/53
|
|
General disorders
Fatigue
|
0.00%
0/54
|
3.8%
2/53
|
|
General disorders
Gait disturbance
|
1.9%
1/54
|
1.9%
1/53
|
|
General disorders
Mucosal inflammation
|
3.7%
2/54
|
0.00%
0/53
|
|
General disorders
Oedema peripheral
|
3.7%
2/54
|
0.00%
0/53
|
|
General disorders
Pyrexia
|
0.00%
0/54
|
3.8%
2/53
|
|
General disorders
Hypothermia
|
1.9%
1/54
|
0.00%
0/53
|
|
General disorders
Multi-organ failure
|
1.9%
1/54
|
0.00%
0/53
|
|
General disorders
Organ failure
|
0.00%
0/54
|
1.9%
1/53
|
|
General disorders
Performance status decreased
|
0.00%
0/54
|
1.9%
1/53
|
|
Hepatobiliary disorders
Cholangitis acute
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Perirectal abscess
|
1.9%
1/54
|
1.9%
1/53
|
|
Infections and infestations
Pneumonia
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Sepsis
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Urinary tract infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Burn oesophageal
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Wound
|
1.9%
1/54
|
0.00%
0/53
|
|
Investigations
Aspiration pleural cavity
|
1.9%
1/54
|
0.00%
0/53
|
|
Investigations
Blood creatinine increased
|
0.00%
0/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Anorexia
|
1.9%
1/54
|
5.7%
3/53
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54
|
5.7%
3/53
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
1/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.9%
1/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
1/54
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/54
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.9%
1/54
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
1.9%
1/54
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.9%
1/54
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
1.9%
1/54
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
1/54
|
0.00%
0/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.9%
1/54
|
0.00%
0/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/54
|
1.9%
1/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/54
|
1.9%
1/53
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Nervous system disorders
Dizziness
|
3.7%
2/54
|
1.9%
1/53
|
|
Nervous system disorders
Syncope
|
0.00%
0/54
|
3.8%
2/53
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/54
|
1.9%
1/53
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/54
|
1.9%
1/53
|
|
Nervous system disorders
Depressed level of consciousness
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Dysaesthesia
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Paresis
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/54
|
1.9%
1/53
|
|
Psychiatric disorders
Confusional state
|
1.9%
1/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Anuria
|
3.7%
2/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Urinary retention
|
1.9%
1/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.9%
1/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/54
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.9%
1/54
|
0.00%
0/53
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.9%
1/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
2/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.7%
2/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.7%
2/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
1.9%
1/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/54
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/54
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
1.9%
1/54
|
0.00%
0/53
|
|
Surgical and medical procedures
Pleurodesis
|
1.9%
1/54
|
0.00%
0/53
|
Other adverse events
| Measure |
AM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
PM Dose Sunitinib Malate (SU011248)
Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.0%
7/54
|
17.0%
9/53
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.8%
8/54
|
11.3%
6/53
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.3%
5/54
|
13.2%
7/53
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.6%
3/54
|
5.7%
3/53
|
|
Ear and labyrinth disorders
Vertigo
|
7.4%
4/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Diarrhoea
|
75.9%
41/54
|
75.5%
40/53
|
|
Gastrointestinal disorders
Stomatitis
|
46.3%
25/54
|
39.6%
21/53
|
|
Gastrointestinal disorders
Nausea
|
46.3%
25/54
|
35.8%
19/53
|
|
Gastrointestinal disorders
Dyspepsia
|
40.7%
22/54
|
28.3%
15/53
|
|
Gastrointestinal disorders
Vomiting
|
29.6%
16/54
|
34.0%
18/53
|
|
Gastrointestinal disorders
Abdominal pain
|
25.9%
14/54
|
24.5%
13/53
|
|
Gastrointestinal disorders
Constipation
|
25.9%
14/54
|
15.1%
8/53
|
|
Gastrointestinal disorders
Abdominal pain upper
|
24.1%
13/54
|
11.3%
6/53
|
|
Gastrointestinal disorders
Oral pain
|
7.4%
4/54
|
11.3%
6/53
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/54
|
15.1%
8/53
|
|
Gastrointestinal disorders
Glossodynia
|
9.3%
5/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/54
|
13.2%
7/53
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.4%
4/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
9.3%
5/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Dysphagia
|
3.7%
2/54
|
7.5%
4/53
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.6%
3/54
|
5.7%
3/53
|
|
General disorders
Asthenia
|
44.4%
24/54
|
37.7%
20/53
|
|
General disorders
Fatigue
|
35.2%
19/54
|
41.5%
22/53
|
|
General disorders
Mucosal inflammation
|
29.6%
16/54
|
17.0%
9/53
|
|
General disorders
Pyrexia
|
16.7%
9/54
|
18.9%
10/53
|
|
General disorders
Chest pain
|
16.7%
9/54
|
17.0%
9/53
|
|
General disorders
Oedema peripheral
|
16.7%
9/54
|
9.4%
5/53
|
|
General disorders
Chills
|
7.4%
4/54
|
5.7%
3/53
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
6/54
|
7.5%
4/53
|
|
Infections and infestations
Bronchitis
|
7.4%
4/54
|
3.8%
2/53
|
|
Infections and infestations
Oral herpes
|
5.6%
3/54
|
5.7%
3/53
|
|
Infections and infestations
Urinary tract infection
|
9.3%
5/54
|
1.9%
1/53
|
|
Investigations
Weight decreased
|
27.8%
15/54
|
32.1%
17/53
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
6/54
|
3.8%
2/53
|
|
Investigations
Blood creatinine increased
|
1.9%
1/54
|
11.3%
6/53
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
2/54
|
7.5%
4/53
|
|
Metabolism and nutrition disorders
Anorexia
|
38.9%
21/54
|
37.7%
20/53
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
1/54
|
15.1%
8/53
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
11.1%
6/54
|
3.8%
2/53
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.6%
3/54
|
5.7%
3/53
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.4%
11/54
|
20.8%
11/53
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
9/54
|
15.1%
8/53
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
8/54
|
11.3%
6/53
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
2/54
|
15.1%
8/53
|
|
Nervous system disorders
Dysgeusia
|
24.1%
13/54
|
28.3%
15/53
|
|
Nervous system disorders
Headache
|
11.1%
6/54
|
15.1%
8/53
|
|
Nervous system disorders
Dizziness
|
16.7%
9/54
|
7.5%
4/53
|
|
Nervous system disorders
Ageusia
|
7.4%
4/54
|
13.2%
7/53
|
|
Psychiatric disorders
Insomnia
|
7.4%
4/54
|
15.1%
8/53
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
31.5%
17/54
|
20.8%
11/53
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
6/54
|
18.9%
10/53
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.8%
8/54
|
11.3%
6/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
6/54
|
13.2%
7/53
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
51.9%
28/54
|
43.4%
23/53
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
33.3%
18/54
|
37.7%
20/53
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
12/54
|
20.8%
11/53
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.5%
10/54
|
22.6%
12/53
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.4%
11/54
|
15.1%
8/53
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
7.4%
4/54
|
13.2%
7/53
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
6/54
|
5.7%
3/53
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
3.7%
2/54
|
7.5%
4/53
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
1/54
|
9.4%
5/53
|
|
Vascular disorders
Hypertension
|
46.3%
25/54
|
43.4%
23/53
|
|
Vascular disorders
Haemorrhage
|
7.4%
4/54
|
7.5%
4/53
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER