Trial Outcomes & Findings for Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy (NCT NCT00672594)
NCT ID: NCT00672594
Last Updated: 2014-08-04
Results Overview
Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.
COMPLETED
PHASE2
30 participants
Baseline and 4 weeks
2014-08-04
Participant Flow
Participant milestones
| Measure |
50mg Sunitinib Malate
Sunitinib Malate 50mg capsule by mouth once daily for 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Sunitinib Malate in Patients With Newly Diagnosed Prostate Cancer Prior to Prostatectomy
Baseline characteristics by cohort
| Measure |
Treatment
n=30 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis
Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %apoptosis (measured as %TUNEL positive cells per high powered field) between pre and post treatment will be reported.
Outcome measures
| Measure |
50 mg Sunitinib Malate
n=23 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Change in Apoptotic Indices Before and After Treatment
|
-2.99 Percentage of TUNEL positive cells
Standard Deviation 24.42
|
PRIMARY outcome
Timeframe: Baseline and 4 weeksPopulation: Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis
Pathologic changes will be described using immuno-histochemical techniques (assessment of apoptotic/proliferative indices and microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the Ki-67 and MVD analysis. Mean difference in %proliferation (Ki67 positive nuclei out of total nuclei) between pre and post treatment will be reported.
Outcome measures
| Measure |
50 mg Sunitinib Malate
n=23 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Change in Proliferation Indices Before and After Treatment
|
-3.19 Percentage of Ki67 positive nuclei
Standard Deviation 6.57
|
SECONDARY outcome
Timeframe: 4 yearsAdverse events were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were converted to version 4.0 for the purposes of ClinicalTrials.gov reporting.
Outcome measures
| Measure |
50 mg Sunitinib Malate
n=30 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity
Grade >= 4 Hematologic
|
1 participants
|
|
Number of Patients Experiencing Grade ≥4 Hematologic or Grade ≥3 Non-hematologic Toxicity
Grade >= 3 Non-Hematologic
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: Two patients did not complete surgery, and five patients did not have adequate tissue samples, leaving 23 patients for analysis
Pathologic changes will be described using immuno-histochemical techniques (assessment of microvessel density (MVD)) using paraffin-embedded samples and freshly cut slides from the block which are deparaffinized and rehydrated through graded alcohol, where applicable. Antigen retrieval will be accomplished by microwaving in citrate buffer from 5 to 7 minutes for the MVD analysis. Results are reported as the difference in pre and post MVD. Units for MVD are number of CD31 cells per high powered field.
Outcome measures
| Measure |
50 mg Sunitinib Malate
n=23 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Change in Pathologic (Microvessel Density).
|
2.75 CD31 cells/High Powered Field
Standard Deviation 7.27
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: 17 patients had adequate measurements at both time points, were on an adequate dose, and took treatment at the correct time points.
We evaluated candidate biomarkers of this pathway to predict for pharmacodynamic response to Sunitinib malate. In addition, a 7 ml plasma sample was collected at baseline and again at 4 weeks on all patients to assess possible biomarkers of response. Reported is the mean percent change in plasma concentration for each marker between 4 weeks and baseline.
Outcome measures
| Measure |
50 mg Sunitinib Malate
n=17 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VEGF
|
135.8 Percent change
Standard Deviation 347.0
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
ANG2
|
-13.0 Percent change
Standard Deviation 28.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
BMP9
|
-54.3 Percent change
Standard Deviation 39.6
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
CRP
|
483.9 Percent change
Standard Deviation 670.0
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
D-DIMER
|
14.7 Percent change
Standard Deviation 22.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
E-CADHERIN
|
-16.3 Percent change
Standard Deviation 31.3
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
E-SELECTIN
|
-7.9 Percent change
Standard Deviation 38.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
ENDOGLIN
|
-14.6 Percent change
Standard Deviation 16.7
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
Groa
|
15.2 Percent change
Standard Deviation 44.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
HGF
|
10.3 Percent change
Standard Deviation 33.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
ICAM1
|
21.9 Percent change
Standard Deviation 32.3
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
IGFBP1
|
107.6 Percent change
Standard Deviation 326.6
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
IGFBP2
|
-5.9 Percent change
Standard Deviation 17.1
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
IGFBP3
|
-9.8 Percent change
Standard Deviation 26.5
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
IL6
|
152.5 Percent change
Standard Deviation 277.5
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
IL8
|
90.0 Percent change
Standard Deviation 45.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
MCP1
|
23.6 Percent change
Standard Deviation 28.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
MMP2
|
0.2 Percent change
Standard Deviation 20.6
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
MMP9
|
-24.2 Percent change
Standard Deviation 66.1
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
OPN
|
8.8 Percent change
Standard Deviation 22.6
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
P-SELECTIN
|
-3.3 Percent change
Standard Deviation 96.1
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
PAI1-ACTIVE
|
121.8 Percent change
Standard Deviation 157.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
PAI1-TOTAL
|
43.2 Percent change
Standard Deviation 65.7
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
PDGF-AA
|
5.8 Percent change
Standard Deviation 74.5
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
PDGF-BB
|
63.8 Percent change
Standard Deviation 118.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
PEDF
|
2.3 Percent change
Standard Deviation 26.2
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
PLGF
|
500.3 Percent change
Standard Deviation 786.7
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
SDF1
|
60.6 Percent change
Standard Deviation 85.1
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
TGFB1
|
-15.0 Percent change
Standard Deviation 42.2
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
TGFB2
|
-10.1 Percent change
Standard Deviation 39.6
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
TGFBR3
|
-8.1 Percent change
Standard Deviation 24.0
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
TSP1
|
-0.9 Percent change
Standard Deviation 44.7
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
TSP2
|
9.0 Percent change
Standard Deviation 46.2
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VCAM1
|
49.8 Percent change
Standard Deviation 68.7
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VEGFD
|
38.6 Percent change
Standard Deviation 50.9
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VEGFC
|
2.2 Percent change
Standard Deviation 90.2
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VEGFR1
|
14.9 Percent change
Standard Deviation 90.9
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VEGFR2
|
-30.0 Percent change
Standard Deviation 24.4
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
Tissue Factor
|
190.1 Percent change
Standard Deviation 570.2
|
|
Change in Systemic Parameters Before and After Sunitinib Malate Treatment.
VWF
|
60.3 Percent change
Standard Deviation 67.2
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Due to changes in the field, this test was not performed due to lack of relevance.
We will perform immunohistochemistry staining on snap frozen specimens for endothelial and pericyte cell staining as previously described (42). Frozen prostate tumor biopsies are sectioned at 6μm thickness and fixed with acetone for 10 minutes. Endogenous peroxidase activity is quenched with 3% hydrogen peroxide for 15 min and then blocked with 5% normal serum. The slides are incubated with the primary antibody (1;100) overnight at 4 C°, and washed with PBS. Negative controls will be included by omission of the primary antibody. Biotinylated donkey antimouse antibody (1:1000, v/v) will be applied for 30 min at room temperature, followed by application of ABC kit (Vector Lab, Inc., Burlingame, USA). Slides are again washed in PBS and the color is developed by 5 min incubation with diaminobenzidine (DAB) solution. Slides are then counterstained with hematoxylin. Mean protein levels are presented.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 yearsPopulation: 21 patients had adequate samples for analysis.
Microarray data of 21 specimens from men enrolled who have undergone a prostatectomy and study treatment were compared to data from 21 prostatectomy only specimens. We used previously developed genomic signatures to measure the deregulation of oncogenic pathways built using Bayesian Probit models for 'metagene' factors from a singular value decomposition of top differentially expressed genes. A Monte Carlo Markov Chain was used to generate the predicted probabilities of pathway activity in normalized samples. We predicted the activity of these pathways, leading to the generation of probability measures that have previously reflected the state of pathway activity. These probability scores are interpreted as gene expression values to describe pathway activity patterns. A probability near 0 indicates a low chance of pathway activity; a probability near 1 indicates a higher likelihood of activity. Differences (treatment - control) in mean probability for each pathway are reported.
Outcome measures
| Measure |
50 mg Sunitinib Malate
n=21 Participants
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Difference in Gene Expression Patterns Using Microarray Analysis
AKT
|
-0.36 Probability
Standard Deviation 0.19
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
BCAT
|
0.24 Probability
Standard Deviation 0.25
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
E2F1
|
0.18 Probability
Standard Deviation 0.25
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
PI3K
|
0.14 Probability
Standard Deviation 0.15
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
ER
|
0.18 Probability
Standard Deviation 0.33
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
MYC
|
0.24 Probability
Standard Deviation 0.23
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
IFNalpha
|
-0.01 Probability
Standard Deviation 0.30
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
IFNgamma
|
-0.01 Probability
Standard Deviation 0.32
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
EGFR
|
-0.08 Probability
Standard Deviation 0.25
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
TGFB
|
-0.17 Probability
Standard Deviation 0.30
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
STAT3
|
-0.11 Probability
Standard Deviation 0.20
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
TNFa
|
0.02 Probability
Standard Deviation 0.31
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
HER2
|
0.03 Probability
Standard Deviation 0.24
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
RAS
|
0.07 Probability
Standard Deviation 0.16
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
HYPOXIA
|
0.11 Probability
Standard Deviation 0.25
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
SRC
|
-0.17 Probability
Standard Deviation 0.16
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
P63
|
-0.09 Probability
Standard Deviation 0.17
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
Acidosis
|
-0.10 Probability
Standard Deviation 0.14
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
Lactic Acidosis
|
-0.22 Probability
Standard Deviation 0.20
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
P53
|
0.05 Probability
Standard Deviation 0.17
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
PR
|
-0.01 Probability
Standard Deviation 0.24
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
Glucose Deprivation
|
0.11 Probability
Standard Deviation 0.21
|
|
Difference in Gene Expression Patterns Using Microarray Analysis
AR
|
0.15 Probability
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: This was an optional test and no patients chose to participate.
Measure Interstitial fluid pressure (IFP) pre-treatment and during treatment to indirectly measure the effect of Sunitinib malate on transcapillary transport and correlate with other biologic evidence of treatment effect.Eligible patients who sign consent will undergo a baseline transrectal ultrasound (TRUS)-guided measurement of tumor IFP. Participants will then begin treatment with daily oral Sunitinib malate with biweekly monitoring for response and toxicity. After 4 weeks of therapy, patients undergo a repeat TRUS and tumor IFP measurement. Following a 1 to 2 week wash out period, patients undergo prostatectomy with pathologic tissue collection. This will be performed as a means to evaluate whether Sunitinib malate has the ability to decrease tumor IFP, and whether this correlates with other tr
Outcome measures
Outcome data not reported
Adverse Events
50 mg Sunitinib Malate
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50 mg Sunitinib Malate
n=30 participants at risk
Only study arm; treatment arm.
Sunitinib Malate : 50mg daily x 4 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Abdominal pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Anal mucositis
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Cheilitis
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Diarrhea
|
43.3%
13/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dyspepsia
|
36.7%
11/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Esophagitis
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Hemorrhoids
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
15/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
5/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Rectal pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Gastrointestinal disorders
Vomitting
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Chills
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Edema face
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Facial pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fatigue
|
73.3%
22/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Fever
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Flu like symptoms
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, sinus
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Infections and infestations
Infections and infestations - Other, urinary
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alanine aminotransferase increased
|
23.3%
7/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Alkaline phosphatase increased
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
26.7%
8/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Blood bilirubin increased
|
13.3%
4/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Lymphocyte count decreased
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Neutrophil count decreased
|
43.3%
13/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Platelet count decreased
|
60.0%
18/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
Weight loss
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Investigations
White blood cell decreased
|
16.7%
5/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
4/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
4/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Concentration impairment
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Dysgeusia
|
70.0%
21/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Memory impairment
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
4/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Renal and urinary disorders
Hematuria
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
23.3%
7/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
5/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hair depigmentation
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, subungual splinter hemorrhage
|
10.0%
3/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, yellowing skin
|
33.3%
10/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
6.7%
2/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hot flashes
|
13.3%
4/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Hypertension
|
33.3%
10/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
|
Vascular disorders
Lymphedema
|
3.3%
1/30 • 4 years
The adverse events were gathered in Common Terminology Criteria for Adverse Events v.3.0, and have been converted to v.4.0 for entry into ClinicalTrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place