Trial Outcomes & Findings for Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer (NCT NCT03240016)
NCT ID: NCT03240016
Last Updated: 2025-01-16
Results Overview
The Overall Response Rate (ORR) will be the percentage of patients that achieve either complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
24 months post treatment, an average of 7.5 months
Results posted on
2025-01-16
Participant Flow
Participant milestones
| Measure |
Pembrolizumab and Abraxane
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Pembrolizumab and Abraxane
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Abraxane With Anti-PD1/PDL1 in Patients With Advanced Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab and Abraxane
n=36 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 months post treatment, an average of 7.5 monthsThe Overall Response Rate (ORR) will be the percentage of patients that achieve either complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.
Outcome measures
| Measure |
Pembrolizumab and Abraxane
n=36 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Percentage of Patients That Respond to Treatment
|
18 Participants
|
SECONDARY outcome
Timeframe: 24 months post treatmentThe duration of response (DOR) is measured from the time that response (PR or CR) criteria are met until the first date that recurrent or progressive disease is objectively documented. CR is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. There can be no appearance of new lesions.
Outcome measures
| Measure |
Pembrolizumab and Abraxane
n=18 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Duration of Response
|
4.4 months
Interval 4.0 to 8.6
|
SECONDARY outcome
Timeframe: 24 months post treatmentProgression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Outcome measures
| Measure |
Pembrolizumab and Abraxane
n=36 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Progression Free Survival Time
|
6.8 months
Interval 4.4 to
not reached
|
SECONDARY outcome
Timeframe: 12 and 24 months post treatmentOverall survival will be documented as the median number of patients alive at 12 and 24 months.
Outcome measures
| Measure |
Pembrolizumab and Abraxane
n=36 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Median Number of Patients Alive at 12 and 24 Months
12 Months
|
0.83 binomial proportion of patients alive
Interval 0.71 to 0.96
|
|
Median Number of Patients Alive at 12 and 24 Months
24 Months
|
0.77 binomial proportion of patients alive
Interval 0.64 to 0.91
|
SECONDARY outcome
Timeframe: from the start of therapy, up to 24 monthsOutcome measures
| Measure |
Pembrolizumab and Abraxane
n=36 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Median Duration of Therapy
|
157 days
Interval 85.0 to 292.0
|
SECONDARY outcome
Timeframe: 24 months post treatment, an average of 7.5 monthsThe percentage of patients that achieve complete response to treatment. Complete response is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.
Outcome measures
| Measure |
Pembrolizumab and Abraxane
n=36 Participants
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Percentage of Patients That Completely Respond to Treatment
|
3 Participants
|
Adverse Events
Pembrolizumab and Abraxane
Serious events: 17 serious events
Other events: 36 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Pembrolizumab and Abraxane
n=36 participants at risk
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Eye disorders
Blurred vision
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Delirium
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Infections and infestations
Encephalitis infection
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Encephalopathy
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Fever
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Cardiac disorders
Sinus bradycardia
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Vascular disorders
Thromboembolic event
|
11.1%
4/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
Other adverse events
| Measure |
Pembrolizumab and Abraxane
n=36 participants at risk
Pembrolizumab 200mg IV D1 Abraxane 100mg/m\^2 IV D1 and D8 21 Day Cycles
Pembrolizumab: 200mg IV D1
Abraxane: 100mg/m\^2 D1 and D8
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
13.9%
5/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
13.9%
5/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Alopecia
|
16.7%
6/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Anemia
|
22.2%
8/36 • Number of events 13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
3/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Arthralgia
|
8.3%
3/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Arthritis
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Bloating
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Blurred vision
|
11.1%
4/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Confusion
|
11.1%
4/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Constipation
|
13.9%
5/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Cough
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Dental caries
|
5.6%
2/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Depression
|
8.3%
3/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
13.9%
5/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Dizziness
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Dysarthria
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Dysgeusia
|
13.9%
5/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Edema limbs
|
8.3%
3/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
4/36 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Fatigue
|
38.9%
14/36 • Number of events 29 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Fever
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
2/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Hematuria
|
8.3%
3/36 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Vascular disorders
Hypertension
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Psychiatric disorders
Insomnia
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
11.1%
4/36 • Number of events 9 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
13.9%
5/36 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Neutrophil count decreased
|
5.6%
2/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
General disorders
Pain
|
8.3%
3/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
2/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Paresthesia
|
13.9%
5/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
9/36 • Number of events 19 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
6/36 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
3/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Infections and infestations
Sepsis
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Vascular disorders
Thromboembolic event
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
3/36 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Urinary tract infection
|
8.3%
3/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
4/36 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
Weight loss
|
11.1%
4/36 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Investigations
White blood cell decreased
|
5.6%
2/36 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.6%
2/36 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years.
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place