Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer (NCT NCT00979992)
NCT ID: NCT00979992
Last Updated: 2020-02-19
Results Overview
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.
Results posted on
2020-02-19
Participant Flow
The study was activated on 4/9/2010 and closed to accrual on 9/30/2013.
Participant milestones
| Measure |
SU11248
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
SU11248
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Study
Ineligible - inadequate pathology
|
1
|
|
Overall Study
Ineligible - wrong cell type
|
2
|
|
Overall Study
Refused - Never Treated
|
2
|
Baseline Characteristics
Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer
Baseline characteristics by cohort
| Measure |
SU11248
n=30 Participants
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Age, Customized
20-29 years
|
2 participants
n=99 Participants
|
|
Age, Customized
30-39 years
|
1 participants
n=99 Participants
|
|
Age, Customized
40-49 years
|
10 participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
9 participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
7 participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
1 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.Population: Eligible and treated patients
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
SU11248
n=30 Participants
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Objective Tumor Response Rate (Complete and Partial Response)
|
6.7 percentage of participants
Interval 1.2 to 19.5
|
PRIMARY outcome
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 monthsPopulation: Eligible and treated patients.
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Outcome measures
| Measure |
SU11248
n=30 Participants
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
The Percentage of Patients Who Survive Progression Free for at Least 6 Months
|
16.7 percentage of participants
Interval 6.8 to 31.9
|
SECONDARY outcome
Timeframe: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, for a total duration of 8.25 yearsPopulation: Eligible and treated patients.
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
SU11248
n=30 Participants
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Overall Survival
|
12.8 months
Interval 6.8 to 17.1
|
SECONDARY outcome
Timeframe: Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter for up to 5 years.Population: Eligible and treated patients.
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1
Outcome measures
| Measure |
SU11248
n=30 Participants
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Progression-free Survival
|
2.7 months
Interval 2.5 to 2.9
|
SECONDARY outcome
Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.Population: Eligible and treated patients
Grade 3 or higher adverse events were graded by CTC AE v 4.
Outcome measures
| Measure |
SU11248
n=30 Participants
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Number of Participants With Grade 3 or Higher Adverse Events
Thromboembolic event
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Blood and lymphatic system disorders - other
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Abdominal distension
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Ascites
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Platelet count decreased
|
6 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Anemia
|
5 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Fatigue
|
4 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Neutrophil count decreased
|
4 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hypertension
|
4 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Abdominal pain
|
3 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Creatinine increased
|
3 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
White blood cell decreased
|
3 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Nausea
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Vomiting
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Lymphocyte count decreased
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hypoalbuminemia
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hyponatremia
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Headache
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Acute kidney injury
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Dyspnea
|
2 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Colitis
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Mucositis oral
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Small intestinal obstruction
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Death, NOS
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Edema trunk
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Pain
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Allergic Reaction
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Investigations, other
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Dehydration
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hyperglycemia
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Neoplasms benign, malignant and unspecified
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Stroke
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hematuria
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Urinary tract obstruction
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Pleural effusion
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Palmar-plantar erythrodysesthesia syndrome
|
1 participants
|
|
Number of Participants With Grade 3 or Higher Adverse Events
Hypotension
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 5 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 5 yearsOutcome measures
Outcome data not reported
Adverse Events
SU11248
Serious events: 15 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SU11248
n=30 participants at risk
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Pain
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Fatigue
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Death Nos
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Immune system disorders
Allergic Reaction
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Platelet Count Decreased
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Creatinine Increased
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Stroke
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Vascular disorders
Thromboembolic Event
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
Other adverse events
| Measure |
SU11248
n=30 participants at risk
SU11248 (sunitinib malate) 50 mg per day for 4 weeks followed by 2 weeks off administered in repeated 6-week cycles until disease progression or adverse effects prohibit further therapy
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Blood and lymphatic system disorders
Anemia
|
76.7%
23/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Endocrine disorders
Hyperthyroidism
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Eye disorders
Eye Disorders - Other
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Eye disorders
Flashing Lights
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Eye disorders
Blurred Vision
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Dyspepsia
|
23.3%
7/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Colitis
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Constipation
|
43.3%
13/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
14/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
10/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Bloating
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Stomach Pain
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Salivary Duct Inflammation
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Abdominal Pain
|
33.3%
10/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Mucositis Oral
|
46.7%
14/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Oral Pain
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Abdominal Distension
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
18/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
13.3%
4/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Rectal Pain
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Ascites
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Gastrointestinal disorders
Gastritis
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Pain
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Localized Edema
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Edema Trunk
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Edema Limbs
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Edema Face
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Fatigue
|
63.3%
19/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Fever
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
General disorders
Chills
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Infections and infestations
Sinusitis
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Investigations - Other
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Weight Loss
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Platelet Count Decreased
|
53.3%
16/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Lymphocyte Count Decreased
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Ggt Increased
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Creatinine Increased
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Neutrophil Count Decreased
|
53.3%
16/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
White Blood Cell Decreased
|
60.0%
18/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Aspartate Aminotransferase Increased
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Alkaline Phosphatase Increased
|
20.0%
6/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Investigations
Alanine Aminotransferase Increased
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
23.3%
7/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
12/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
6/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
26.7%
8/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Paresthesia
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Leukoencephalopathy
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Intracranial Hemorrhage
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Headache
|
33.3%
10/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Extrapyramidal Disorder
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Dysgeusia
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Nervous system disorders
Amnesia
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Psychiatric disorders
Insomnia
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Psychiatric disorders
Depression
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Psychiatric disorders
Anxiety
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Psychiatric disorders
Agitation
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Urinary Urgency
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Urinary Frequency
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Renal Calculi
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Hemoglobinuria
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Hematuria
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
4/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
5/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
4/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
3.3%
1/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
20.0%
6/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Vascular disorders
Thromboembolic Event
|
10.0%
3/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Vascular disorders
Hypotension
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Vascular disorders
Hypertension
|
33.3%
10/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
|
Vascular disorders
Hot Flashes
|
6.7%
2/30 • Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.
|
Additional Information
Angela M. Kuras, Associate Director of Administration and Operations
NRG Oncology Statistics and Data Management Center - Buffalo Office
Phone: 716-845-5702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60