Trial Outcomes & Findings for Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer (NCT NCT02516670)
NCT ID: NCT02516670
Last Updated: 2023-06-07
Results Overview
prostate-specific antigen decline will be defined as ≥ 50% from baseline measurement
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
up to 24 weeks
Results posted on
2023-06-07
Participant Flow
12 subjects were Screen fails
Participant milestones
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
16
|
|
Overall Study
COMPLETED
|
34
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel With or Without Ascorbic Acid in Treating Patients With Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=99 Participants
|
69 years
n=107 Participants
|
70 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 24 weeksprostate-specific antigen decline will be defined as ≥ 50% from baseline measurement
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participates With a Decline in Prostate-specific Antigen From Their Baseline Measurement
|
13 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after the last dose of study drugNumber of participants experiencing fatigue, nausea, bone pain, and anorexia as defined by CTCAE 4.0
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participants With Adverse Events
fatigue
|
25 Participants
|
11 Participants
|
|
Number of Participants With Adverse Events
nausea
|
17 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
bone pain
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
anorexia
|
12 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksThe number of dose reductions and total number of completed cycles will be summarized by study arm.
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Average Number of Times Docetaxel Had Dose Reductions
|
7 dose reductions
Interval 1.0 to 256.0
|
9 dose reductions
Interval 1.0 to 109.0
|
SECONDARY outcome
Timeframe: Up to 30 days after last dose of study drugNumber of serious adverse events of all types as defined by Common Terminology Criteria for Adverse Events 4.0. A serious adverse event is an undesirable sign, symptom, or medical condition that: * Results in death * Is life threatening * Requires inpatient hospitalization or causes prolongation of existing hospitalization for \>24 hours * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Is an important medical event
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Serious Adverse Events
grade 1
|
0 events
|
0 events
|
|
Number of Serious Adverse Events
grade 2
|
4 events
|
0 events
|
|
Number of Serious Adverse Events
grade 3
|
18 events
|
6 events
|
|
Number of Serious Adverse Events
grade 4
|
3 events
|
0 events
|
|
Number of Serious Adverse Events
grade 5
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Up to 24 weeksNumber of serious adverse events defined as grade 3 or higher (fatigue, nausea, bone pain, and anorexia) in participates as defined by CTCAE 4.0
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Number of Participates Experiencing Serious Adverse Events (SAE)
fatigue
|
0 Participants
|
0 Participants
|
|
Number of Participates Experiencing Serious Adverse Events (SAE)
nausea
|
0 Participants
|
0 Participants
|
|
Number of Participates Experiencing Serious Adverse Events (SAE)
bone pain
|
0 Participants
|
0 Participants
|
|
Number of Participates Experiencing Serious Adverse Events (SAE)
anorexia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to course 6 of therapy (18 weeks)The (FACT-P) is made up of 39 question, with the total score ranging between 0 and 156 with 0 being the best and 156 as the worst.
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Change in Quality of Life (QoL) as Measured by the FACT-P Questionnaire
|
116.4580 score on a scale
Interval 110.5926 to 122.3235
|
113.9834 score on a scale
Interval 105.171 to 122.7958
|
SECONDARY outcome
Timeframe: Up to 3 yearsTo determine the rPFS of participates that receive at least one dose of ascorbic acid compared to those who received placebo
Outcome measures
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 Participants
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 Participants
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Radiographic Progression Free Survival (rPFS)
|
10.12 months
Interval 5.85 to 14.69
|
9.97 months
Interval 5.32 to
The upper limit of the KM curve has not reached 50%, therefore there is no estimate for the upper confidence limit on the median.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksTo determine whether ascorbic acid alters docetaxel exposure and compare between treatment arms, pharmacokinetics samples will be collected prior to, during, and after ascorbic acid and docetaxel infusions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to course 6 (18 weeks)Correlative analyses will assess the association between ascorbic acid and lipid peroxidation (F2-isoprostanes) in the two study arms, globally, and over time. Comparisons of ascorbic acid and F2-isoprostanes by study arm at cycle 1, cycle 2, cycle 4 and cycle 6, accounting for baseline measures obtained from the same patient, will be made by taking differences between post baseline and baseline values and comparing these differences between arms of the study with t-tests. Regression will also be used to assess the association between F2-isoprostane and ascorbic acid at cycle 4 and at cycle 6.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksOutcome measures
Outcome data not reported
Adverse Events
Arm A (Docetaxel, Ascorbic Acid)
Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths
Arm B (Docetaxel, Placebo)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 participants at risk
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 participants at risk
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
Neutrophil count decreased
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.8%
3/34 • Number of events 3 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Hematuria
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/34 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
General disorders
Fever
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/34 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Myocardialinfarction
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Investigations
Investigations - Other specify
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
Other adverse events
| Measure |
Arm A (Docetaxel, Ascorbic Acid)
n=34 participants at risk
Patients receive docetaxel IV on day 1 and ascorbic acid IV twice weekly. The first ascorbic acid treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Ascorbic Acid: Given IV
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Quality-of-Life Assessment: Ancillary studies
|
Arm B (Docetaxel, Placebo)
n=16 participants at risk
Patients receive docetaxel IV on day 1 and placebo IV twice weekly.The first placebo treatment will be given on day 1 (same day as docetaxel). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Docetaxel: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pharmacological Study: Correlative studies
Placebo: Given IV
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
General disorders
Fatigue
|
67.6%
23/34 • Number of events 43 • Up to 30 days after the last dose of study drug
|
68.8%
11/16 • Number of events 27 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
4/34 • Number of events 11 • Up to 30 days after the last dose of study drug
|
25.0%
4/16 • Number of events 5 • Up to 30 days after the last dose of study drug
|
|
General disorders
Alopecia
|
52.9%
18/34 • Number of events 19 • Up to 30 days after the last dose of study drug
|
25.0%
4/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
17/34 • Number of events 34 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 6 • Up to 30 days after the last dose of study drug
|
|
General disorders
Aneroxia
|
38.2%
13/34 • Number of events 19 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Psychiatric disorders
Anxiety
|
5.9%
2/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
2/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
back pain
|
14.7%
5/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Eye disorders
Blurred vision
|
8.8%
3/34 • Number of events 3 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
2/34 • Number of events 12 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 6 • Up to 30 days after the last dose of study drug
|
|
Injury, poisoning and procedural complications
Bruising
|
8.8%
3/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 3 • Up to 30 days after the last dose of study drug
|
|
General disorders
chills
|
20.6%
7/34 • Number of events 8 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.9%
2/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
General disorders
Cold symptoms
|
8.8%
3/34 • Number of events 3 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
47.1%
16/34 • Number of events 27 • Up to 30 days after the last dose of study drug
|
31.2%
5/16 • Number of events 5 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.6%
6/34 • Number of events 7 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
General disorders
Decreased Appetite
|
8.8%
3/34 • Number of events 3 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
General disorders
Dehydratin
|
8.8%
3/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Psychiatric disorders
Depression
|
11.8%
4/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhea
|
67.6%
23/34 • Number of events 43 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 6 • Up to 30 days after the last dose of study drug
|
|
General disorders
Dizziness
|
26.5%
9/34 • Number of events 13 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Dry Mouth
|
11.8%
4/34 • Number of events 6 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Dysgeusia
|
14.7%
5/34 • Number of events 8 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 5 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.7%
5/34 • Number of events 6 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Vascular disorders
Edema
|
20.6%
7/34 • Number of events 10 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
2/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Injury, poisoning and procedural complications
Fall
|
8.8%
3/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
General disorders
Fever
|
8.8%
3/34 • Number of events 6 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
2/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Vascular disorders
Flushing
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.8%
4/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Headache
|
17.6%
6/34 • Number of events 9 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Vascular disorders
Hot flashes
|
17.6%
6/34 • Number of events 8 • Up to 30 days after the last dose of study drug
|
25.0%
4/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.8%
3/34 • Number of events 7 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 8 • Up to 30 days after the last dose of study drug
|
|
Vascular disorders
Hypertension
|
29.4%
10/34 • Number of events 28 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 7 • Up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.8%
3/34 • Number of events 3 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
HypoKalemia
|
5.9%
2/34 • Number of events 8 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 3 • Up to 30 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.7%
5/34 • Number of events 9 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 11 • Up to 30 days after the last dose of study drug
|
|
Psychiatric disorders
Insomnia
|
14.7%
5/34 • Number of events 8 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 3 • Up to 30 days after the last dose of study drug
|
|
General disorders
Light Headedness
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Investigations
Lymphocyte Count Decreased
|
29.4%
10/34 • Number of events 31 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 6 • Up to 30 days after the last dose of study drug
|
|
General disorders
Malaise
|
11.8%
4/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 6 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Mucositis oral
|
20.6%
7/34 • Number of events 8 • Up to 30 days after the last dose of study drug
|
25.0%
4/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
11.8%
4/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
52.9%
18/34 • Number of events 34 • Up to 30 days after the last dose of study drug
|
37.5%
6/16 • Number of events 7 • Up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Neuropathy sensory
|
26.5%
9/34 • Number of events 14 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 7 • Up to 30 days after the last dose of study drug
|
|
Investigations
Neutropenia
|
29.4%
10/34 • Number of events 28 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Investigations
Neutrophil count decreased
|
11.8%
4/34 • Number of events 9 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
General disorders
Nocturia
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
General disorders
Pain
|
20.6%
7/34 • Number of events 20 • Up to 30 days after the last dose of study drug
|
43.8%
7/16 • Number of events 20 • Up to 30 days after the last dose of study drug
|
|
Nervous system disorders
Paresthesia
|
14.7%
5/34 • Number of events 5 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Investigations
Platelet count decreased
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
0.00%
0/16 • Up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.8%
3/34 • Number of events 3 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
4/34 • Number of events 9 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Cardiac disorders
Tachycardia
|
5.9%
2/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
General disorders
Taste Changes
|
8.8%
3/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
2/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
2/34 • Number of events 4 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Infections and infestations
UTI Infection
|
5.9%
2/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
8/34 • Number of events 12 • Up to 30 days after the last dose of study drug
|
12.5%
2/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
|
Eye disorders
Watering Eyes
|
5.9%
2/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Investigations
Weight Gain
|
2.9%
1/34 • Number of events 2 • Up to 30 days after the last dose of study drug
|
18.8%
3/16 • Number of events 4 • Up to 30 days after the last dose of study drug
|
|
Investigations
Weight Loss
|
11.8%
4/34 • Number of events 7 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 1 • Up to 30 days after the last dose of study drug
|
|
Investigations
White Blood Cell Count Decreased
|
23.5%
8/34 • Number of events 19 • Up to 30 days after the last dose of study drug
|
6.2%
1/16 • Number of events 2 • Up to 30 days after the last dose of study drug
|
Additional Information
Channing Paller Associate Professor Urologic Oncology
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 4109558239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place