Trial Outcomes & Findings for Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC) (NCT NCT02060370)
NCT ID: NCT02060370
Last Updated: 2020-02-27
Results Overview
Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
Results posted on
2020-02-27
Participant Flow
Sixty participants enrolled between August 2014 and March 2016. Participants recruited from The University of Texas MD Anderson Cancer Center, Cleveland Clinic Foundation, Fox Chase Cancer Center, and University of North Carolina Lineberger Cancer Center). All participants had confirmed treatment naive metastatic clear cell renal cell carcinoma.
One participant did not take the study medication due to declining mental health status before the first dose was initiated. Consequently, only 59 patients were included in the final analysis.
Participant milestones
| Measure |
Alternating Sunitinib
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Alternating Sunitinib
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)
Baseline characteristics by cohort
| Measure |
Sunitinib
n=60 Participants
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center (MSKCC) Risk Factor
Good
|
13 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center (MSKCC) Risk Factor
Intermediate
|
40 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center (MSKCC) Risk Factor
Poor
|
6 Participants
n=5 Participants
|
|
Memorial Sloan Kettering Cancer Center (MSKCC) Risk Factor
Unknown
|
1 Participants
n=5 Participants
|
|
Number of Metastatic Sites
|
2 Number of metastatic sites
n=5 Participants
|
|
Metastatic Sites
Lung
|
39 Participants
n=5 Participants
|
|
Metastatic Sites
Lymph node
|
10 Participants
n=5 Participants
|
|
Metastatic Sites
Liver
|
8 Participants
n=5 Participants
|
|
Metastatic Sites
Bone
|
3 Participants
n=5 Participants
|
|
Metastatic Sites
Other
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 monthsDetermine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Outcome measures
| Measure |
Alternating Sunitinib
n=59 Participants
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
Rate of Toxicity
Grade>=3, of all 3 adverse events
|
15 Participants
|
|
Rate of Toxicity
Fatigue, Grade >=3
|
8 Participants
|
|
Rate of Toxicity
Diarrhea, Grade >=3
|
5 Participants
|
|
Rate of Toxicity
Hand-foot syndrome, Grade >=3
|
3 Participants
|
SECONDARY outcome
Timeframe: 17 monthsProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Alternating Sunitinib
n=59 Participants
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
Progression-Free Survival (PFS)
|
13.7 months
Interval 10.9 to 16.3
|
SECONDARY outcome
Timeframe: Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4
Outcome measures
| Measure |
Alternating Sunitinib
n=59 Participants
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Any grade ≥3 event
|
35 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Alkaline phosphatase increased
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Anemia
|
6 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Dehydration
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Diarrhea
|
5 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Fatigue
|
8 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Pancreatic insufficiency
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Headache
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Hypertension
|
16 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Hyponatremia
|
2 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Hypophosphatemia
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Lymphocyte count decreased
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Mucositis oral
|
5 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Gout
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Neutrophil count decreased
|
8 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Hand-foot syndrome
|
3 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Platelet count decreased
|
2 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Thromboembolic event
|
3 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Urticaria
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Vascular access complication
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Vomiting
|
1 Participants
|
|
The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
White blood cell decreased
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Out of the 59 participants only 29 encountered a dose reduction. The number of dose reductions a participant experienced was also reported with the percentage being based on the 29 participants who had a reduction.
Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.
Outcome measures
| Measure |
Alternating Sunitinib
n=59 Participants
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
1 Dose Reduction
|
7 Participants
|
|
Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
2 Dose Reductions
|
14 Participants
|
|
Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
3 Dose Reductions
|
3 Participants
|
|
Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
4 Dose Reductions
|
5 Participants
|
SECONDARY outcome
Timeframe: 36 weeks from the start of treatmentPopulation: The number of surveys collected at week 0, 12,24, and 36 are 54, 49, 44, and 35 surveys.The number of surveys with a grade 3 toxicity collected at week 0, 12, 24, and 36 are 14, 11, 12, and 10 surveys. The number of surveys without a grade 3 toxicity collected at week 0, 12, 24, and 36 are 40, 38, 32, and 25 surveys.
Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36. The score range is from 0 to 180 with higher scores reflecting a better quality of life. The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity. The total number of surveys changes as the weeks progress.
Outcome measures
| Measure |
Alternating Sunitinib
n=54 Participants
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
|
|---|---|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
All Participants- week 0
|
87.8 Score on a scale
Interval 57.7 to 108.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
All Participants- week 12
|
88 Score on a scale
Interval 46.0 to 106.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
All Participants- week 24
|
86 Score on a scale
Interval 44.0 to 108.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
All Participants- week 36
|
89 Score on a scale
Interval 61.0 to 106.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Grade 3 tox - week 0
|
86.8 Score on a scale
Interval 56.0 to 108.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Grade 3 tox - week 12
|
79.5 Score on a scale
Interval 46.0 to 100.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Grade 3 tox - week 24
|
79 Score on a scale
Interval 44.0 to 106.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Grade 3 tox - week 36
|
83 Score on a scale
Interval 63.0 to 106.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
No grade 3 tox - week 0
|
88.8 Score on a scale
Interval 52.7 to 105.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
No grade 3 tox - week 12
|
89.8 Score on a scale
Interval 46.8 to 106.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
No grade 3 tox - week 24
|
91.8 Score on a scale
Interval 55.2 to 108.0
|
|
Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
No grade 3 tox - week 36
|
93.8 Score on a scale
Interval 61.0 to 104.0
|
SECONDARY outcome
Timeframe: Not applicable due data not generated due to timing and budgetary issuesPopulation: Data were not collected due to timing and budgetary issues.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib
Serious events: 35 serious events
Other events: 59 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Sunitinib
n=59 participants at risk
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
|
|---|---|
|
Investigations
Alkaline phosphatase increased
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Anemia
|
10.2%
6/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
General disorders
Fatigue
|
13.6%
8/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Diarrhea
|
8.5%
5/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Endocrine disorders
Pancreatic insufficiency
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Nervous system disorders
Headache
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Vascular disorders
Hypertension
|
27.1%
16/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.4%
2/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Lymphocyte count decreased
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.5%
5/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Gout
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
13.6%
8/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
3.4%
2/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Vascular disorders
Thromboembolic event
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Vascular disorders
Vascular access complication
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
Other adverse events
| Measure |
Sunitinib
n=59 participants at risk
Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.
Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Alanine aminotransferase increased
|
18.6%
11/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Alkaline phosphatase increased
|
10.2%
6/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Anal mucositis
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Anemia
|
54.2%
32/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Anorexia
|
20.3%
12/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Aspartate aminotransferase increased
|
32.2%
19/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Bloating
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Blood bilirubin increased
|
10.2%
6/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
CD4 lymphocytes decreased
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Constipation
|
10.2%
6/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Creatinine increased
|
35.6%
21/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Diarrhea
|
76.3%
45/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Dry mouth
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Nervous system disorders
Dysesthesia
|
10.2%
6/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Nervous system disorders
Dysgeusia
|
45.8%
27/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
22.0%
13/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.3%
12/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
General disorders
Edema
|
15.3%
9/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Endocrine disorders
TSH increased
|
8.5%
5/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.6%
8/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
General disorders
Fatigue
|
83.1%
49/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
11.9%
7/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Nervous system disorders
Headache
|
10.2%
6/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Renal and urinary disorders
Hemoglobinuria
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.9%
7/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Vascular disorders
Hypertension
|
16.9%
10/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.3%
12/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.9%
7/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.5%
5/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Endocrine disorders
Hypothyroidism
|
25.4%
15/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
11.9%
7/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
54.2%
32/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Nausea
|
44.1%
26/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
39.0%
23/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
General disorders
Non-cardiac chest pain
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
13.6%
8/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
54.2%
32/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.7%
24/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Nervous system disorders
Paresthesia
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Platelet count decreased
|
61.0%
36/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Renal and urinary disorders
Proteinuria
|
39.0%
23/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
8/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Hair hypopigmentation
|
6.8%
4/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
20.3%
12/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Vascular disorders
Thromboembolic event
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
5.1%
3/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Gastrointestinal disorders
Vomiting
|
23.7%
14/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Eye disorders
Watering eyes
|
16.9%
10/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Investigations
Weight loss
|
13.6%
8/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
57.6%
34/59 • Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
|
Additional Information
Dr. Eric Jonasch, MD/Professor, Genitourinary Medical Oncology
University of Texas MD Anderson Cancer Center
Phone: 713-792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place