Trial Outcomes & Findings for Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery (NCT NCT02169284)
NCT ID: NCT02169284
Last Updated: 2020-07-07
Results Overview
EGFR phosphorylation will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater phosphorylation. The difference between the placebo group and the erlotinib hydrochloride group will be tested as-randomized using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 18 hours after last study drug dose (on day 28)
Results posted on
2020-07-07
Participant Flow
50 were consented, 13 participants ineligible
Participant milestones
| Measure |
Group I (Erlotinib Hydrochloride)
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
13
|
|
Overall Study
COMPLETED
|
24
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group I (Erlotinib Hydrochloride)
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Group I (Erlotinib Hydrochloride)
n=24 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=13 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Participant Age
|
70.25 years
n=5 Participants
|
69.32 years
n=7 Participants
|
69.93 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
13 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Karnofsky Performance Status
80
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Karnofsky Performance Status
90
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Karnofsky Performance Status
100
|
19 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ever Smoked
Yes
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ever Smoked
No
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Current Smoker
Yes
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Current Smoker
No
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Systolic Blood Pressure
|
134.62 mmHg
n=5 Participants
|
136.69 mmHg
n=7 Participants
|
135.35 mmHg
n=5 Participants
|
|
Diastolic Blood Pressure
|
76.62 mmHg
n=5 Participants
|
78.23 mmHg
n=7 Participants
|
77.19 mmHg
n=5 Participants
|
|
Pulse
|
74.75 beats per minute
n=5 Participants
|
69.85 beats per minute
n=7 Participants
|
73.03 beats per minute
n=5 Participants
|
|
Temperature
|
97.67 degrees Fahrenheit
n=5 Participants
|
97.48 degrees Fahrenheit
n=7 Participants
|
97.61 degrees Fahrenheit
n=5 Participants
|
|
Height
|
174.77 cm
n=5 Participants
|
174.40 cm
n=7 Participants
|
174.64 cm
n=5 Participants
|
|
Weight
|
89.67 kg
n=5 Participants
|
86.83 kg
n=7 Participants
|
88.67 kg
n=5 Participants
|
|
Body Mass Index
|
29.37 kg/m^2
n=5 Participants
|
28.25 kg/m^2
n=7 Participants
|
28.96 kg/m^2
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Genitalia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Prostate
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Musculoskeletal
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Skin
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Abdomen
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Appearance
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Head, Eyes, Ears, Nose, Throat
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Heart
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Lungs
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Vascular
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Breasts
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Chest
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Lymph Nodes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Neurologic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Pelvis
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Rectal
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Medical History / Baseline Presence of Abnormality or Disease
Thyroid
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 hours after last study drug dose (on day 28)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
EGFR phosphorylation will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater phosphorylation. The difference between the placebo group and the erlotinib hydrochloride group will be tested as-randomized using a two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=15 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=8 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor
Nucleus P-EGFR in Benign Tissue
|
0.216 optical density
Standard Deviation 0.063
|
0.181 optical density
Standard Deviation 0.073
|
|
EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor
Cytoplasm P-EGFR in Benign Tissue
|
0.159 optical density
Standard Deviation 0.046
|
0.133 optical density
Standard Deviation 0.062
|
|
EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor
Membrane P-EGFR in Benign Tissue
|
0.179 optical density
Standard Deviation 0.053
|
0.148 optical density
Standard Deviation 0.074
|
|
EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor
Entire Cell P-EGFR in Benign Tissue
|
0.190 optical density
Standard Deviation 0.054
|
0.159 optical density
Standard Deviation 0.069
|
SECONDARY outcome
Timeframe: Up to 18 hours after last study drug dose (on day 28)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
EGFR phosphorylation will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater phosphorylation.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=21 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=11 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose
Nucleus P-EGFR Tumor Tissue
|
0.175 Optical Density (OD)
Standard Deviation 0.060
|
0.155 Optical Density (OD)
Standard Deviation 0.059
|
|
EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose
Cytoplasm P-EGFR Tumor Tissue
|
0.161 Optical Density (OD)
Standard Deviation 0.053
|
0.146 Optical Density (OD)
Standard Deviation 0.070
|
|
EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose
Membrane P-EGFR Tumor Tissue
|
0.170 Optical Density (OD)
Standard Deviation 0.058
|
0.154 Optical Density (OD)
Standard Deviation 0.072
|
|
EGFR Phosphorylation in Neoplastic Bladder Epithelium 9-18 Hours Post-study Dose
Entire Cell P-EGFR Tumor Tissue
|
0.170 Optical Density (OD)
Standard Deviation 0.056
|
0.151 Optical Density (OD)
Standard Deviation 0.061
|
SECONDARY outcome
Timeframe: Baseline, day 8, and day 16 (day of surgery)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
Will be summarized by treatment arm (and, if applicable, by visit) with appropriate descriptive statistics.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=24 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=13 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Pharmacokinetic Parameters: Erlotinib in Blood
Baseline
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Pharmacokinetic Parameters: Erlotinib in Blood
Day 8
|
169.7 ng/mL
Standard Deviation 581.3
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Pharmacokinetic Parameters: Erlotinib in Blood
Day 16 (Surgery)
|
2218.4 ng/mL
Standard Deviation 1096.1
|
0.3 ng/mL
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Baseline, day 8, and day 16 (day of surgery)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
Will be summarized by treatment arm (and, if applicable, by visit) with appropriate descriptive statistics.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=24 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=13 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Pharmacokinetic Parameters: OSI-420 in Blood
Baseline
|
0.0 ng/mL
Standard Deviation 0.0
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Pharmacokinetic Parameters: OSI-420 in Blood
Day 8
|
2.5 ng/mL
Standard Deviation 7.3
|
0.0 ng/mL
Standard Deviation 0.0
|
|
Pharmacokinetic Parameters: OSI-420 in Blood
Day 16 (Surgery)
|
44.4 ng/mL
Standard Deviation 34.6
|
0.0 ng/mL
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline up to 18 hours after last study drug dose (on day 28)Population: A participant in the placebo group had no survey response at baseline.
A well documented survey called the International Prostate Symptom Score (I-PSS) of urination symptoms which correlates with prostatic hyperplasia in men will be filled out by men at baseline and end of study. The I-PSS is an 8-item survey; 7 questions scored from 0-5 where 0 is 'none' or 'not at all' and 5 is 'five times' or 'almost always'. The sum of the scores for the first 7 questions has a total range of 0-35 where 0 is asymptomatic, 1-7 is mild symptoms, 8-19 is moderate symptoms, and 20-35 are severe symptoms. A final quality of life question is scored from 0-6 where 0 (delighted) to 6 (terrible). This question serves as a conversation starting point between the patient and physician.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=15 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=7 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Baseline · Severe (score of 20-35)
|
1 Participants
|
0 Participants
|
|
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Baseline · Mild (score of 1-7)
|
7 Participants
|
3 Participants
|
|
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Baseline · Moderate (score of 8-19)
|
7 Participants
|
3 Participants
|
|
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Surgery Visit · Mild (score of 1-7)
|
7 Participants
|
5 Participants
|
|
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Surgery Visit · Moderate (score of 8-19)
|
7 Participants
|
2 Participants
|
|
Frequency of Urination Symptoms in Men Only, Graded According to International Prostate Symptom Score (I-PSS)
Surgery Visit · Severe (score of 20-35)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of surgery (approximately day 16)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
E-Cadherin expression will be assessed using Immunohistochemistry (IHC), greater membrane optical density was associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=15 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=9 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Expression of E-cadherin
Benign Tissue
|
0.615 Optical Density (OD)
Standard Deviation 0.126
|
0.572 Optical Density (OD)
Standard Deviation 0.198
|
|
Expression of E-cadherin
Tumor Tissue
|
0.616 Optical Density (OD)
Standard Deviation 0.070
|
0.563 Optical Density (OD)
Standard Deviation 0.079
|
SECONDARY outcome
Timeframe: At time of surgery (approximately day 16)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
Ki-67 expression will be assessed using Immunohistochemistry (IHC), greater positivity was associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=15 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=9 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Percentage of Cells Expressing Ki67
Benign Tissue
|
0.093 percentage
Standard Deviation 0.142
|
0.080 percentage
Standard Deviation 0.111
|
|
Percentage of Cells Expressing Ki67
Tumor Tissue
|
0.148 percentage
Standard Deviation 0.142
|
0.170 percentage
Standard Deviation 0.137
|
SECONDARY outcome
Timeframe: At time of surgery (approximately day 16)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained.
Phosphorylated ERK will be assessed using Immunohistochemistry (IHC), greater mean optical density is associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=12 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=5 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Difference Between Normal and Neoplastic Tissue Phosphorylated ERK
Nucleus P-ERK Normal-Tumor
|
-0.071 Optical Density (OD)
Standard Deviation 0.167
|
-0.077 Optical Density (OD)
Standard Deviation 0.183
|
|
Difference Between Normal and Neoplastic Tissue Phosphorylated ERK
Cytoplasm P-ERK Normal-Tumor
|
-0.104 Optical Density (OD)
Standard Deviation 0.187
|
-0.098 Optical Density (OD)
Standard Deviation 0.170
|
|
Difference Between Normal and Neoplastic Tissue Phosphorylated ERK
Entire Cell P-ERK Normal-Tumor
|
-0.084 Optical Density (OD)
Standard Deviation 0.171
|
-0.085 Optical Density (OD)
Standard Deviation 0.173
|
SECONDARY outcome
Timeframe: At time of surgery (approximately day 16)Population: Number analyzed differs from number of participants in each arm for two reasons: sample size insufficient for analysis and sample not obtained. As well as there was not enough tissue to complete this analysis for all participants.
p53 expression will be assessed using Immunohistochemistry (IHC), greater nucleus optical density and positivity was associated with greater expression. A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Outcome measures
| Measure |
Group I (Erlotinib Hydrochloride)
n=13 Participants
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=8 Participants
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Difference Between Normal and Neoplastic Tissue of p53
|
-0.052 Optical Density (OD)
Standard Deviation 0.185
|
-0.115 Optical Density (OD)
Standard Deviation 0.305
|
SECONDARY outcome
Timeframe: At time of surgery (approximately day 16)Population: This analysis was not completed after discussions with DCP. Participant samples were rationed for multiple analyses, Let-7 analysis was determined to be low on the priority list and it was decided to forego this analysis.
A two-sample t-test with normalizing transformation if necessary or Wilcoxon rank-sum test will be used.
Outcome measures
Outcome data not reported
Adverse Events
Group I (Erlotinib Hydrochloride)
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Group II (Placebo)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I (Erlotinib Hydrochloride)
n=24 participants at risk
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=13 participants at risk
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Surgical and medical procedures
Surgical and Medical Procedures, Other
|
0.00%
0/24 • up to 9 weeks
|
15.4%
2/13 • Number of events 2 • up to 9 weeks
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
Other adverse events
| Measure |
Group I (Erlotinib Hydrochloride)
n=24 participants at risk
Participants receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
Group II (Placebo)
n=13 participants at risk
Participants receive placebo PO QD on days 1, 8, and 15. Participants then undergo TURBT or cystectomy on day 16.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders, Other
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Endocrine disorders
Endocrine Orders, Other
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Eye disorders
Dry Eye
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
2/24 • Number of events 3 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Bloating
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
9/24 • Number of events 13 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
4.2%
1/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Disorders, Other
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Mucositis Oral
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
General disorders
Fatigue
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
15.4%
2/13 • Number of events 2 • up to 9 weeks
|
|
Infections and infestations
Infections and Infestations, Other
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
12.5%
3/24 • Number of events 3 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Investigations
Blood Bilirubin Increased
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Investigations
Investigations, Other
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissues Disorder, Other
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Amnesia
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Cognitive Disturbance
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Number of events 4 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Hypersomnia
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Paresthesia
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Nervous system disorders
Tremor
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Renal and urinary disorders
Bladder Spasm
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Renal and urinary disorders
Hematuria
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Renal and urinary disorders
Urinary Incontinence
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Renal and urinary disorders
Urinary Retention
|
12.5%
3/24 • Number of events 3 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Renal and urinary disorders
Urinary Tract Pain
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/24 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and Mediastinal Disorders, Other
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
8.3%
2/24 • Number of events 3 • up to 9 weeks
|
7.7%
1/13 • Number of events 1 • up to 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
4/24 • Number of events 5 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
25.0%
6/24 • Number of events 11 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
16.7%
4/24 • Number of events 5 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and Subcuteaneous Tissue Disorders, Other
|
12.5%
3/24 • Number of events 3 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
2/24 • Number of events 2 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Surgical and medical procedures
Surgical and Medical Procedures, Other
|
0.00%
0/24 • up to 9 weeks
|
15.4%
2/13 • Number of events 2 • up to 9 weeks
|
|
Vascular disorders
Flushing
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Vascular disorders
Hot Flashes
|
4.2%
1/24 • Number of events 1 • up to 9 weeks
|
0.00%
0/13 • up to 9 weeks
|
|
Vascular disorders
Hypertension
|
37.5%
9/24 • Number of events 11 • up to 9 weeks
|
30.8%
4/13 • Number of events 4 • up to 9 weeks
|
Additional Information
Dr. Tracy Downs
University of Wisconsin Carbone Cancer Center
Phone: 608-263-9534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60