Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer (NCT NCT01158222)
NCT ID: NCT01158222
Last Updated: 2018-09-14
Results Overview
Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
after 6 months of treatment (4 cycles)
Results posted on
2018-09-14
Participant Flow
5 additional patients were consented but not enrolled in the study. No information was collected on them and they are not included in the patient flow. Demographics information was not collected on these patients.
Participant milestones
| Measure |
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given orally
laboratory biomarker analysis: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
polymorphism analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Arm I
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given orally
laboratory biomarker analysis: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
polymorphism analysis: Correlative studies
|
|---|---|
|
Overall Study
Not eligible for intermediate phase
|
17
|
Baseline Characteristics
Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Arm I
n=37 Participants
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given orally
laboratory biomarker analysis: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
polymorphism analysis: Correlative studies
|
|---|---|
|
Age, Customized
40-49
|
3 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
9 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
18 Participants
n=5 Participants
|
|
Age, Customized
70-79
|
6 Participants
n=5 Participants
|
|
Age, Customized
80-89
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: after 6 months of treatment (4 cycles)Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Outcome measures
| Measure |
Arm I
n=20 Participants
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given orally
laboratory biomarker analysis: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
polymorphism analysis: Correlative studies
|
|---|---|
|
Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
|
20 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment, day 1, and day 28 of every cyclePopulation: Did not complete this analysis. Data not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 28 of each cyclePopulation: Did not complete this analysis. Data not collected.
Outcome measures
Outcome data not reported
Adverse Events
Arm I
Serious events: 13 serious events
Other events: 37 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I
n=37 participants at risk
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given orally
laboratory biomarker analysis: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
polymorphism analysis: Correlative studies
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder - other
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Chills
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Edema Trunk
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Fever
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Infection and infestation - other
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Lung infection
|
2.7%
1/37 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • Number of events 1
|
|
Investigations
Weight Gain
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Intracranial Hemorrhage
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Syncope
|
2.7%
1/37 • Number of events 2
|
|
Renal and urinary disorders
Hematuria
|
2.7%
1/37 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
2.7%
1/37 • Number of events 1
|
|
Renal and urinary disorders
Renal and urinary disorders - other
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - other
|
2.7%
1/37 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
Thromboembolic Event
|
2.7%
1/37 • Number of events 1
|
Other adverse events
| Measure |
Arm I
n=37 participants at risk
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
sunitinib malate: Given orally
laboratory biomarker analysis: Correlative studies
reverse transcriptase-polymerase chain reaction: Correlative studies
polymorphism analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
70.3%
26/37 • Number of events 67
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - other
|
5.4%
2/37 • Number of events 2
|
|
Endocrine disorders
Hyperthyroidism
|
8.1%
3/37 • Number of events 3
|
|
Endocrine disorders
Hypothyroidism
|
48.6%
18/37 • Number of events 24
|
|
Gastrointestinal disorders
Abdominal distension
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain
|
24.3%
9/37 • Number of events 12
|
|
Gastrointestinal disorders
Cheilitis
|
10.8%
4/37 • Number of events 7
|
|
Gastrointestinal disorders
Constipation
|
48.6%
18/37 • Number of events 32
|
|
Gastrointestinal disorders
Dental Caries
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
62.2%
23/37 • Number of events 88
|
|
Gastrointestinal disorders
Dry Mouth
|
10.8%
4/37 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
51.4%
19/37 • Number of events 35
|
|
Gastrointestinal disorders
Flatulence
|
8.1%
3/37 • Number of events 4
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
13.5%
5/37 • Number of events 6
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
10.8%
4/37 • Number of events 9
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
16.2%
6/37 • Number of events 6
|
|
Gastrointestinal disorders
Hemorrhoids
|
18.9%
7/37 • Number of events 7
|
|
Gastrointestinal disorders
Lip Pain
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis Oral
|
83.8%
31/37 • Number of events 107
|
|
Gastrointestinal disorders
Nausea
|
67.6%
25/37 • Number of events 75
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
Oral Pain
|
8.1%
3/37 • Number of events 5
|
|
Gastrointestinal disorders
Vomiting
|
35.1%
13/37 • Number of events 25
|
|
General disorders
Chills
|
8.1%
3/37 • Number of events 5
|
|
General disorders
Edema limbs
|
29.7%
11/37 • Number of events 15
|
|
General disorders
Fatigue
|
94.6%
35/37 • Number of events 127
|
|
General disorders
Fever
|
10.8%
4/37 • Number of events 8
|
|
General disorders
General Disorders - Other
|
10.8%
4/37 • Number of events 4
|
|
General disorders
Localized Edema
|
5.4%
2/37 • Number of events 3
|
|
General disorders
Pain
|
40.5%
15/37 • Number of events 35
|
|
Infections and infestations
Lung Infection
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Mucosal Infection
|
5.4%
2/37 • Number of events 3
|
|
Infections and infestations
Nail Infection
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
8.1%
3/37 • Number of events 3
|
|
Infections and infestations
Rhinitis Infective
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Skin Infection
|
5.4%
2/37 • Number of events 9
|
|
Infections and infestations
Tooth Infection
|
5.4%
2/37 • Number of events 4
|
|
Infections and infestations
Upper Respiratory Infection
|
13.5%
5/37 • Number of events 6
|
|
Infections and infestations
Urinary Tract Infection
|
10.8%
4/37 • Number of events 5
|
|
Injury, poisoning and procedural complications
Bruising
|
8.1%
3/37 • Number of events 6
|
|
Investigations
Alanine Aminotransferase Increased
|
27.0%
10/37 • Number of events 18
|
|
Investigations
Alkaline Phosphatase Increased
|
8.1%
3/37 • Number of events 5
|
|
Investigations
Aspartate Aminotranferase Increased
|
35.1%
13/37 • Number of events 34
|
|
Investigations
Blood Bilirubin Increased
|
10.8%
4/37 • Number of events 7
|
|
Investigations
Creatinine Increased
|
45.9%
17/37 • Number of events 39
|
|
Investigations
Lymphocyte Count Decreased
|
10.8%
4/37 • Number of events 6
|
|
Investigations
Neutrophil Count Decreased
|
48.6%
18/37 • Number of events 57
|
|
Investigations
Platelet Count Decreased
|
83.8%
31/37 • Number of events 115
|
|
Investigations
Weight Gain
|
8.1%
3/37 • Number of events 6
|
|
Investigations
Weight Loss
|
37.8%
14/37 • Number of events 16
|
|
Investigations
White Blood Cell Decreased
|
67.6%
25/37 • Number of events 73
|
|
Metabolism and nutrition disorders
Anorexia
|
51.4%
19/37 • Number of events 53
|
|
Metabolism and nutrition disorders
Dehydration
|
13.5%
5/37 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.4%
2/37 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperclycemia
|
21.6%
8/37 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.2%
6/37 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
8.1%
3/37 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.5%
5/37 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.4%
2/37 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.4%
2/37 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.8%
4/37 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.0%
10/37 • Number of events 32
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.5%
5/37 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.3%
9/37 • Number of events 121
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.4%
2/37 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
13.5%
5/37 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
10.8%
4/37 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
5.4%
2/37 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.3%
9/37 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
29.7%
11/37 • Number of events 17
|
|
Nervous system disorders
Cognitive Disturbance
|
10.8%
4/37 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
16.2%
6/37 • Number of events 6
|
|
Nervous system disorders
Dysgeusia
|
70.3%
26/37 • Number of events 58
|
|
Nervous system disorders
Headache
|
27.0%
10/37 • Number of events 21
|
|
Nervous system disorders
Syncope
|
5.4%
2/37 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
10.8%
4/37 • Number of events 4
|
|
Psychiatric disorders
Depression
|
13.5%
5/37 • Number of events 6
|
|
Psychiatric disorders
Insomnia
|
8.1%
3/37 • Number of events 3
|
|
Renal and urinary disorders
Hematuria
|
5.4%
2/37 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.9%
7/37 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.1%
3/37 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.9%
7/37 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
5.4%
2/37 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
8.1%
3/37 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.8%
4/37 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
37.8%
14/37 • Number of events 22
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
16.2%
6/37 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
5.4%
2/37 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
10.8%
4/37 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar Erythrodysesthesia Syndrome
|
54.1%
20/37 • Number of events 78
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
21.6%
8/37 • Number of events 13
|
|
Skin and subcutaneous tissue disorders
Purpura
|
21.6%
8/37 • Number of events 18
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
27.0%
10/37 • Number of events 19
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
5.4%
2/37 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders - Other
|
16.2%
6/37 • Number of events 10
|
|
Vascular disorders
Hot Flashes
|
8.1%
3/37 • Number of events 3
|
|
Vascular disorders
Hypertension
|
59.5%
22/37 • Number of events 45
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.1%
3/37 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place