Trial Outcomes & Findings for Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer (NCT NCT02218606)
NCT ID: NCT02218606
Last Updated: 2024-12-10
Results Overview
using the RECIST criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Up to 100 weeks
Results posted on
2024-12-10
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
17
|
7
|
|
Overall Study
NOT COMPLETED
|
25
|
32
|
Reasons for withdrawal
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
15
|
28
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Noncompliance
|
1
|
0
|
|
Overall Study
Initiation of new drug for prostate cancer
|
2
|
0
|
|
Overall Study
Other
|
2
|
1
|
|
Overall Study
Never started treatment
|
0
|
1
|
Baseline Characteristics
Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
n=42 Participants
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
n=39 Participants
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.5 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 100 weeksusing the RECIST criteria
Outcome measures
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
n=42 Participants
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
n=39 Participants
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
Progression Free Survival (rPFS)
|
6.4 months
Interval 3.8 to 10.6
|
14.8 months
Interval 10.6 to 16.4
|
SECONDARY outcome
Timeframe: Up to 100 weeksFor each patient, use a waterfall plot to report the percent change in PSA from baseline to 12 weeks (or earlier for those who discontinue therapy) and the maximum decline in PSA that occurs at any point after treatment.
Outcome measures
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
n=42 Participants
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
n=39 Participants
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
PSA Progression Free Survival (PSA PFS)
|
9.2 months
Interval 7.4 to 13.4
|
15.1 months
Interval 10.9 to 19.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: N/A - data were not collected
per RECIST criteria
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearThe NCI CTCAE version 4.0 will be used for recording and grading AEs.
Outcome measures
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
n=42 Participants
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
n=39 Participants
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
Participants With Maximum Overall Grade ≥3 AEs
Participants without maximum overall grade ≥3
|
15 Participants
|
16 Participants
|
|
Participants With Maximum Overall Grade ≥3 AEs
Participants with maximum overall grade ≥3 AEs
|
27 Participants
|
23 Participants
|
Adverse Events
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
Serious events: 22 serious events
Other events: 27 other events
Deaths: 15 deaths
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
Serious events: 28 serious events
Other events: 23 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
n=42 participants at risk
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
n=39 participants at risk
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
4/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Investigations
Creatinine increased
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
General disorders
Death NOS
|
35.7%
15/42 • 1 year
|
71.8%
28/39 • 1 year
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Nervous system disorders
Dizziness
|
2.4%
1/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.4%
1/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
General disorders
Fatigue
|
2.4%
1/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.8%
2/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
General disorders
Fever
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Vascular disorders
Hematoma
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
4.8%
2/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Vascular disorders
Hypertension
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Injury, poisoning and procedural complications
Intraoperative hemorrhage
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Infections and infestations
Lung infection
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Investigations
Neutrophil count decreased
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
General disorders
Pain
|
14.3%
6/42 • 1 year
|
15.4%
6/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Platelet count decreased
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Renal and urinary disorders
Renal colic
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Infections and infestations
Sepsis
|
4.8%
2/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Investigations
Serum amylase increased
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Infections and infestations
Skin infection
|
2.4%
1/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Nervous system disorders
Stroke
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/42 • 1 year
|
2.6%
1/39 • 1 year
|
Other adverse events
| Measure |
Abiraterone Acetate 1000 mg po Daily + Prednisone 5 mg po BID
n=42 participants at risk
Arm 1: Abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
prednisone 5 mg po BID
|
Cabazitaxel 25 mg/m2 IV + Abiraterone Acetate 1000 mg po Daily
n=39 participants at risk
Arm 2: Cabazitaxel 25 mg/m2 IV + abiraterone acetate 1000 mg po daily + prednisone 5 mg po BID
Abiraterone acetate 1000 mg po daily
Cabazitaxel 25 mg/m2 IV
prednisone 5 mg po BID
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
19.0%
8/42 • 1 year
|
15.4%
6/39 • 1 year
|
|
Psychiatric disorders
Agitation
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
3/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
9.5%
4/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
9.5%
4/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
12/42 • 1 year
|
20.5%
8/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
3/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.8%
10/42 • 1 year
|
25.6%
10/39 • 1 year
|
|
Eye disorders
Blurred vision
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
3/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Infections and infestations
Bronchial infection
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Injury, poisoning and procedural complications
Bruising
|
9.5%
4/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
38.1%
16/42 • 1 year
|
25.6%
10/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
10/42 • 1 year
|
35.9%
14/39 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Psychiatric disorders
Depression
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
14/42 • 1 year
|
33.3%
13/39 • 1 year
|
|
Nervous system disorders
Dizziness
|
9.5%
4/42 • 1 year
|
12.8%
5/39 • 1 year
|
|
Gastrointestinal disorders
Dry Mouth
|
9.5%
4/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
2/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
4.8%
2/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
2/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
3/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
9/42 • 1 year
|
33.3%
13/39 • 1 year
|
|
General disorders
Edema limbs
|
23.8%
10/42 • 1 year
|
12.8%
5/39 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
3/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
General disorders
Fatigue
|
64.3%
27/42 • 1 year
|
59.0%
23/39 • 1 year
|
|
General disorders
Fever
|
7.1%
3/42 • 1 year
|
17.9%
7/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
General disorders
Gait disturbance
|
11.9%
5/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
3/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
2.4%
1/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
3/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Nervous system disorders
Headache
|
14.3%
6/42 • 1 year
|
17.9%
7/39 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
19.0%
8/42 • 1 year
|
20.5%
8/39 • 1 year
|
|
Vascular disorders
Hot flashes
|
19.0%
8/42 • 1 year
|
17.9%
7/39 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
4/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Vascular disorders
Hypertension
|
26.2%
11/42 • 1 year
|
28.2%
11/39 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Infections and infestations
Infection
|
7.1%
3/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.1%
3/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/42 • 1 year
|
15.4%
6/39 • 1 year
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
4.8%
2/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
3/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
45.2%
19/42 • 1 year
|
41.0%
16/39 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
4.8%
2/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
Investigations
Neutrophil count decreased
|
7.1%
3/42 • 1 year
|
12.8%
5/39 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
4.8%
2/42 • 1 year
|
2.6%
1/39 • 1 year
|
|
General disorders
Pain
|
59.5%
25/42 • 1 year
|
59.0%
23/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
3/42 • 1 year
|
17.9%
7/39 • 1 year
|
|
Nervous system disorders
Paresthesia
|
2.4%
1/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pelvic Pain
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
General disorders
Peripheral Edema
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Nervous system disorders
Peripheral motor neuropathy
|
7.1%
3/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
4/42 • 1 year
|
12.8%
5/39 • 1 year
|
|
Investigations
Platelet count decreased
|
9.5%
4/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Infections and infestations
Pneumonia
|
4.8%
2/42 • 1 year
|
0.00%
0/39 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.8%
2/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Nervous system disorders
Sensory Neuropathy
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.4%
1/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/42 • 1 year
|
7.7%
3/39 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
38.1%
16/42 • 1 year
|
43.6%
17/39 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
21.4%
9/42 • 1 year
|
33.3%
13/39 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
4.8%
2/42 • 1 year
|
5.1%
2/39 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
4.8%
2/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
Renal and urinary disorders
Urinary urgency
|
11.9%
5/42 • 1 year
|
10.3%
4/39 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
7/42 • 1 year
|
28.2%
11/39 • 1 year
|
|
Investigations
Weight gain
|
9.5%
4/42 • 1 year
|
15.4%
6/39 • 1 year
|
|
Investigations
Weight loss
|
11.9%
5/42 • 1 year
|
10.3%
4/39 • 1 year
|
Additional Information
Dr. Susan Slovin, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4472
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place