Trial Outcomes & Findings for Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer (NCT NCT04262154)
NCT ID: NCT04262154
Last Updated: 2026-05-11
Results Overview
Failure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
2 years
Results posted on
2026-05-11
Participant Flow
Participant milestones
| Measure |
Cohort 1
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Cohort 2
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
8
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
17
|
6
|
Reasons for withdrawal
| Measure |
Cohort 1
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Cohort 2
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Physician Decision
|
8
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=20 Participants
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Cohort 2
n=8 Participants
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=44 Participants
|
61 years
n=10 Participants
|
64.5 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=44 Participants
|
8 Participants
n=10 Participants
|
28 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=44 Participants
|
7 Participants
n=10 Participants
|
25 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=44 Participants
|
6 Participants
n=10 Participants
|
19 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=44 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=44 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=44 Participants
|
8 Participants
n=10 Participants
|
28 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 2 yearsFailure is defined as: biochemical failure, radiographic progression defined by PCWG3, or death from any cause.
Outcome measures
| Measure |
Cohort 1
n=20 Participants
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Cohort 2
n=8 Participants
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
|---|---|---|
|
Failure-free Rate at 2 Years
Participants with failure-free rate at 2 years
|
13 Participants
|
7 Participants
|
|
Failure-free Rate at 2 Years
Participants without failure-free rate at 2 years
|
7 Participants
|
1 Participants
|
Adverse Events
Cohort 1
Serious events: 5 serious events
Other events: 20 other events
Deaths: 8 deaths
Cohort 2
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1
n=20 participants at risk
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Cohort 2
n=8 participants at risk
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Infections and infestations
COVID-19
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
General disorders
Pyrexia
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
Other adverse events
| Measure |
Cohort 1
n=20 participants at risk
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
Cohort 2
n=8 participants at risk
Participants will have untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy for their prostate cancer. Group 1 and 2. The first 20 patients enrolled will be in Group 1 and the remaining patients (and those who are already on a GnRH analog) will be assigned to Group 2. All study participants will receive treatment with atezolizumab, abiraterone acetate, prednisone, GnRH analog, and SBRT, at the same doses.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
2/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Reproductive system and breast disorders
Testicular pain
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Endocrine disorders
Thyroiditis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Infections and infestations
Urethritis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Amylase increased
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
2/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Cardiac disorders
Angina pectoris
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
3/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Blood creatinine increased
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Reproductive system and breast disorders
Breast pain
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Infections and infestations
COVID-19
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
General disorders
Chills
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Psychiatric disorders
Confusional state
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Infections and infestations
Conjunctivitis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Infections and infestations
Coronavirus infection
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
4/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
5/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Eye disorders
Dry eye
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
2/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
4/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Renal and urinary disorders
Dysuria
|
10.0%
2/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
2/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Fatigue
|
35.0%
7/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Reproductive system and breast disorders
Gynaecomastia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Gastrointestinal disorders
Haematochezia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Renal and urinary disorders
Haematuria
|
25.0%
5/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Nervous system disorders
Headache
|
35.0%
7/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Vascular disorders
Hot flush
|
50.0%
10/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Vascular disorders
Hypertension
|
15.0%
3/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Injection site reaction
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Psychiatric disorders
Insomnia
|
15.0%
3/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Psychiatric disorders
Libido decreased
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Lipase increased
|
0.00%
0/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
General disorders
Localised oedema
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Malaise
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Nervous system disorders
Memory impairment
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Renal and urinary disorders
Micturition urgency
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Nervous system disorders
Migraine with aura
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Infections and infestations
Nail infection
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
15.0%
3/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
General disorders
Oedema peripheral
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Pain
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
2/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Cardiac disorders
Palpitations
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Nervous system disorders
Paraesthesia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Reproductive system and breast disorders
Penile pain
|
10.0%
2/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Eye disorders
Periorbital oedema
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Infections and infestations
Pneumonia
|
15.0%
3/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Renal and urinary disorders
Pollakiuria
|
10.0%
2/20 • 2 years
|
37.5%
3/8 • 2 years
|
|
Gastrointestinal disorders
Proctalgia
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.0%
1/20 • 2 years
|
12.5%
1/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
General disorders
Pyrexia
|
10.0%
2/20 • 2 years
|
25.0%
2/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Psychiatric disorders
Restlessness
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
5.0%
1/20 • 2 years
|
0.00%
0/8 • 2 years
|
Additional Information
Dr. Dana Rathkopf, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4379
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place