Trial Outcomes & Findings for Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer (NCT NCT01505868)
NCT ID: NCT01505868
Last Updated: 2021-07-30
Results Overview
The MTD was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
170 participants
Primary outcome timeframe
6 months
Results posted on
2021-07-30
Participant Flow
Participants were treated at MD Anderson Cancer Center in Houston, TX and Karmanos Cancer institute in Detroit, MI
170 participants enrolled, 10 were phase I participants, 1 participant withdrew in phase I
Participant milestones
| Measure |
Phase I Cabazitaxel + Carboplatin Dose Zero
Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 3 mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose One
Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose Two
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel
Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
|
Phase II Cabazitaxel + Carboplatin
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
79
|
81
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
79
|
81
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Cabazitaxel + Carboplatin Dose Zero
Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 3 mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose One
Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose Two
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel
Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
|
Phase II Cabazitaxel + Carboplatin
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Cabazitaxel With or Without Carboplatin in Treating Patients With Previously Treated Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Phase I Cabazitaxel + Carboplatin Dose Zero
n=3 Participants
Intravenous cabazitaxel 20 mg/m2 and carboplatin AUC 3 every 21 days up to 10 doses
|
Phase I Cabazitaxel + Carboplatin Dose One
n=3 Participants
Intravenous cabazitaxel 20 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
Phase I Cabazitaxel + Carboplatin Dose Two
n=3 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
Phase II Cabazitaxel
n=79 Participants
Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
|
Phase II Cabazitaxel + Carboplatin
n=81 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
74 years
n=7 Participants
|
69 years
n=5 Participants
|
66 years
n=4 Participants
|
68 years
n=21 Participants
|
67 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
169 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
126 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
130 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
79 participants
n=4 Participants
|
81 participants
n=21 Participants
|
169 participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 1 and 2
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
123 Participants
n=8 Participants
|
|
Prostate-specific antigen (PSA)
|
380.4 µg/L
n=5 Participants
|
89.5 µg/L
n=7 Participants
|
217.6 µg/L
n=5 Participants
|
23.7 µg/L
n=4 Participants
|
33.8 µg/L
n=21 Participants
|
28.75 µg/L
n=8 Participants
|
|
Bone metastases
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Bone metastases
Yes
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
156 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe MTD was defined as the highest dose cohort studied in which one of six or fewer patients experienced a dose-limiting toxicity.
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=9 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Maximum Tolerated Dosage (MTD) of Cabazitaxel-carboplatin in the Phase I Portion of Study
|
25 mg/m^2
|
—
|
PRIMARY outcome
Timeframe: From the first dose until progression of disease or death, whichever comes first, up to 5 yearsPFS is the time from the first dose until progression of disease or death, whichever comes first. PFS times will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=79 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=81 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Progression Free Survival (PFS) of Cabazitaxel-carboplatin Versus Cabazitaxel in the Phase II Portion of Study
|
4.5 months
Interval 3.5 to 5.7
|
7.3 months
Interval 5.5 to 8.2
|
SECONDARY outcome
Timeframe: 5 yearsPercentage of participants with a greater than 50% decrease in measurable values of PSA during treatment from their baseline PSA.
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=66 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=68 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Prostate Specific Antigen (PSA) Response Rate
|
40.9 percentage of participants
Interval 30.2 to 51.8
|
61.7 percentage of participants
Interval 51.4 to 72.6
|
SECONDARY outcome
Timeframe: 5 yearsPercentage of participants with a greater than 50% decrease in measurable values of bone-specific alkaline phosphatase during treatment from their baseline values
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=34 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=50 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Bone-Specific Alkaline Phosphatase Response
|
29.4 percentage of participants
Interval 19.0 to 39.0
|
62 percentage of participants
Interval 51.4 to 72.6
|
SECONDARY outcome
Timeframe: 5 yearsPercentage of participants with a greater than 50% decrease in measurable values of urine n-telopeptides during treatment from their baseline values.
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=20 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=24 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Urine N-Telopeptides Response
|
55 percentage of participants
Interval 33.2 to 76.8
|
62.5 percentage of participants
Interval 42.1 to 81.9
|
SECONDARY outcome
Timeframe: Time from date of treatment start until date of death due to any cause or last follow up, up to 5 yearsTime from date of treatment start until date of death due to any cause or last follow up.
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=79 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=81 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Overall Survival (OS)
|
17.3 months
Interval 13.8 to 21.9
|
18.5 months
Interval 16.7 to 21.9
|
SECONDARY outcome
Timeframe: Time from date of treatment start until date of death due to any cause or last follow up, up to 5 yearsGrade 3: Serious reaction which requires medical treatment Grade 4: Life threatening. Grade 5 Death.
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=79 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=81 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Phase II Most Common Grade 3-5 Adverse Events
Fatique
|
9 Participants
|
20 Participants
|
|
Phase II Most Common Grade 3-5 Adverse Events
Anemia
|
4 Participants
|
23 Participants
|
|
Phase II Most Common Grade 3-5 Adverse Events
Neutropenia
|
4 Participants
|
16 Participants
|
|
Phase II Most Common Grade 3-5 Adverse Events
Thrombocytopenia
|
1 Participants
|
14 Participants
|
POST_HOC outcome
Timeframe: 5 yearsPFS and OS were reported for participants with and without AVPC-MS in the cabazitaxel vs cabazitaxel + carboplatin treatment groups
Outcome measures
| Measure |
Phase I Cabazitaxel + Carboplatin
n=26 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel + Carboplatin
n=30 Participants
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|
|
Aggressive Variant Prostate Carcinoma-Metastatic (ACPC-MS) Phenotypes Correlated to Response
Cabazitaxel + carboplatin PFS
|
7.5 months
Interval 4.4 to 9.6
|
6.5 months
Interval 3.9 to 8.4
|
|
Aggressive Variant Prostate Carcinoma-Metastatic (ACPC-MS) Phenotypes Correlated to Response
Cabazitaxel OS
|
8.5 months
Interval 4.8 to
below the level of detection
|
21.7 months
Interval 17.4 to
below the level of detection
|
|
Aggressive Variant Prostate Carcinoma-Metastatic (ACPC-MS) Phenotypes Correlated to Response
Cabazitaxel + carboplatin OS
|
20.2 months
Interval 13.3 to 37.2
|
21.5 months
Interval 9.1 to
below the level of detection
|
|
Aggressive Variant Prostate Carcinoma-Metastatic (ACPC-MS) Phenotypes Correlated to Response
Cabazitaxel PFS
|
1.7 months
Interval 1.3 to
below the level of detection
|
6.3 months
Interval 5.9 to 10.9
|
Adverse Events
Phase I Cabazitaxel + Carboplatin Dose Zero
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Cabazitaxel + Carboplatin Dose One
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase I Cabazitaxel + Carboplatin Dose Two
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase II Cabazitaxel
Serious events: 3 serious events
Other events: 78 other events
Deaths: 63 deaths
Phase II Cabazitaxel + Carboplatin
Serious events: 4 serious events
Other events: 81 other events
Deaths: 69 deaths
Serious adverse events
| Measure |
Phase I Cabazitaxel + Carboplatin Dose Zero
n=3 participants at risk
Intravenous cabazitaxel 20mg/m2 and carboplatin area under the curve (AUC) 3mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose One
n=3 participants at risk
Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose Two
n=3 participants at risk
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel
n=79 participants at risk
Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
|
Phase II Cabazitaxel + Carboplatin
n=81 participants at risk
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
0.00%
0/81 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/79 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
General disorders
Fever
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/79 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
0.00%
0/81 • 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 2 • 5 years
|
0.00%
0/81 • 5 years
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/79 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Investigations
WBC decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/79 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Phase I Cabazitaxel + Carboplatin Dose Zero
n=3 participants at risk
Intravenous cabazitaxel 20mg/m2 and carboplatin area under the curve (AUC) 3mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose One
n=3 participants at risk
Intravenous cabazitaxel 20 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase I Cabazitaxel + Carboplatin Dose Two
n=3 participants at risk
Intravenous cabazitaxel 25 mg/m2 and carboplatin area under the curve (AUC) 4 mg/mL per min every 21 days
|
Phase II Cabazitaxel
n=79 participants at risk
Intravenous cabazitaxel 25 mg/m2 every 21 days up to 10 doses
|
Phase II Cabazitaxel + Carboplatin
n=81 participants at risk
Intravenous cabazitaxel 25 mg/m2 and carboplatin AUC 4 every 21 days up to 10 doses
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 7 • 5 years
|
8.6%
7/81 • Number of events 8 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 4 • 5 years
|
4.9%
4/81 • Number of events 4 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
3.8%
3/79 • Number of events 3 • 5 years
|
4.9%
4/81 • Number of events 4 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
17.7%
14/79 • Number of events 14 • 5 years
|
29.6%
24/81 • Number of events 26 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • 5 years
|
33.3%
1/3 • 5 years
|
100.0%
3/3 • 5 years
|
25.3%
20/79 • Number of events 31 • 5 years
|
58.0%
47/81 • Number of events 112 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
8.9%
7/79 • Number of events 7 • 5 years
|
21.0%
17/81 • Number of events 21 • 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
2.5%
2/79 • Number of events 2 • 5 years
|
3.7%
3/81 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
6.3%
5/79 • Number of events 5 • 5 years
|
14.8%
12/81 • Number of events 14 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
2.5%
2/79 • Number of events 2 • 5 years
|
8.6%
7/81 • Number of events 8 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
2.5%
2/81 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/79 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
17.7%
14/79 • Number of events 23 • 5 years
|
43.2%
35/81 • Number of events 58 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
2.5%
2/79 • Number of events 3 • 5 years
|
4.9%
4/81 • Number of events 6 • 5 years
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
66.7%
2/3 • 5 years
|
8.9%
7/79 • Number of events 8 • 5 years
|
9.9%
8/81 • Number of events 11 • 5 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
2.5%
2/79 • Number of events 2 • 5 years
|
4.9%
4/81 • Number of events 5 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
5.1%
4/79 • Number of events 4 • 5 years
|
9.9%
8/81 • Number of events 12 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • 5 years
|
100.0%
3/3 • 5 years
|
66.7%
2/3 • 5 years
|
55.7%
44/79 • Number of events 102 • 5 years
|
66.7%
54/81 • Number of events 160 • 5 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
66.7%
2/3 • 5 years
|
7.6%
6/79 • Number of events 6 • 5 years
|
16.0%
13/81 • Number of events 16 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
13.9%
11/79 • Number of events 11 • 5 years
|
19.8%
16/81 • Number of events 22 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
66.7%
2/3 • 5 years
|
24.1%
19/79 • Number of events 34 • 5 years
|
42.0%
34/81 • Number of events 71 • 5 years
|
|
General disorders
Edema limbs
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
13.9%
11/79 • Number of events 13 • 5 years
|
12.3%
10/81 • Number of events 13 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epitaxis
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 2 • 5 years
|
7.4%
6/81 • Number of events 8 • 5 years
|
|
General disorders
Fatigue
|
33.3%
1/3 • 5 years
|
100.0%
3/3 • 5 years
|
100.0%
3/3 • 5 years
|
73.4%
58/79 • Number of events 125 • 5 years
|
85.2%
69/81 • Number of events 272 • 5 years
|
|
General disorders
Fever
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
6.3%
5/79 • Number of events 5 • 5 years
|
11.1%
9/81 • Number of events 14 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 10 • 5 years
|
3.7%
3/81 • Number of events 3 • 5 years
|
|
General disorders
Flu like symptoms
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
7.4%
6/81 • Number of events 8 • 5 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
3.8%
3/79 • Number of events 5 • 5 years
|
4.9%
4/81 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Genralized muscle weakness
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 2 • 5 years
|
6.2%
5/81 • Number of events 7 • 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
7.6%
6/79 • Number of events 10 • 5 years
|
8.6%
7/81 • Number of events 7 • 5 years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
3.8%
3/79 • Number of events 4 • 5 years
|
12.3%
10/81 • Number of events 14 • 5 years
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
6.2%
5/81 • Number of events 5 • 5 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
3.8%
3/79 • Number of events 3 • 5 years
|
4.9%
4/81 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
2.5%
2/81 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
17.7%
14/79 • Number of events 17 • 5 years
|
19.8%
16/81 • Number of events 24 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
3.8%
3/79 • Number of events 3 • 5 years
|
7.4%
6/81 • Number of events 11 • 5 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
7.6%
6/79 • Number of events 7 • 5 years
|
4.9%
4/81 • Number of events 4 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
3.8%
3/79 • Number of events 3 • 5 years
|
6.2%
5/81 • Number of events 5 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
6.3%
5/79 • Number of events 6 • 5 years
|
12.3%
10/81 • Number of events 18 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
8.9%
7/79 • Number of events 9 • 5 years
|
16.0%
13/81 • Number of events 31 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesenia
|
66.7%
2/3 • 5 years
|
66.7%
2/3 • 5 years
|
33.3%
1/3 • 5 years
|
7.6%
6/79 • Number of events 7 • 5 years
|
43.2%
35/81 • Number of events 51 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatrenia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 5 • 5 years
|
7.4%
6/81 • Number of events 7 • 5 years
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
2.5%
2/79 • Number of events 3 • 5 years
|
7.4%
6/81 • Number of events 9 • 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
6.3%
5/79 • Number of events 6 • 5 years
|
2.5%
2/81 • Number of events 2 • 5 years
|
|
General disorders
Localized Edema
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
3.7%
3/81 • Number of events 3 • 5 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
11.4%
9/79 • Number of events 17 • 5 years
|
9.9%
8/81 • Number of events 19 • 5 years
|
|
General disorders
Malaise
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
9.9%
8/81 • Number of events 9 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
7.6%
6/79 • Number of events 11 • 5 years
|
8.6%
7/81 • Number of events 14 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 4 • 5 years
|
4.9%
4/81 • Number of events 6 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 5 years
|
66.7%
2/3 • 5 years
|
66.7%
2/3 • 5 years
|
35.4%
28/79 • Number of events 60 • 5 years
|
70.4%
57/81 • Number of events 170 • 5 years
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
7.6%
6/79 • Number of events 7 • 5 years
|
19.8%
16/81 • Number of events 32 • 5 years
|
|
General disorders
Non-cardiac cest pain
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
5.1%
4/79 • Number of events 5 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pain
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
8.9%
7/79 • Number of events 14 • 5 years
|
11.1%
9/81 • Number of events 9 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
3.8%
3/79 • Number of events 4 • 5 years
|
9.9%
8/81 • Number of events 11 • 5 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
10.1%
8/79 • Number of events 10 • 5 years
|
18.5%
15/81 • Number of events 18 • 5 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
33.3%
1/3 • 5 years
|
6.3%
5/79 • Number of events 8 • 5 years
|
19.8%
16/81 • Number of events 23 • 5 years
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
6.3%
5/79 • Number of events 7 • 5 years
|
39.5%
32/81 • Number of events 83 • 5 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
2.5%
2/81 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
7.4%
6/81 • Number of events 7 • 5 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
0.00%
0/81 • 5 years
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 4 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • 5 years
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
1.3%
1/79 • Number of events 1 • 5 years
|
1.2%
1/81 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 5 years
|
66.7%
2/3 • 5 years
|
0.00%
0/3 • 5 years
|
17.7%
14/79 • Number of events 25 • 5 years
|
37.0%
30/81 • Number of events 63 • 5 years
|
|
Investigations
Weight loss
|
33.3%
1/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
5.1%
4/79 • Number of events 5 • 5 years
|
14.8%
12/81 • Number of events 14 • 5 years
|
|
Investigations
WBC decreased
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
0.00%
0/3 • 5 years
|
10.1%
8/79 • Number of events 11 • 5 years
|
29.6%
24/81 • Number of events 50 • 5 years
|
Additional Information
Paul Corn, MD PHD- Chair Ad Interim, Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 563-7208
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place