Trial Outcomes & Findings for Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers (NCT NCT02749903)
NCT ID: NCT02749903
Last Updated: 2021-10-26
Results Overview
The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Up to 32 weeks
Results posted on
2021-10-26
Participant Flow
Participant milestones
| Measure |
Enzalutamide
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=46 Participants
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
25 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 32 weeksThe best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
Outcome measures
| Measure |
Enzalutamide
n=46 Participants
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Best Overall Response Rate
|
4.3 percentage of patients
Interval 0.5 to 14.8
|
SECONDARY outcome
Timeframe: Up to 32 months post study enrollmentProgression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Enzalutamide
n=46 Participants
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Progression-free Survival
|
5.6 months
Interval 3.7 to 7.5
|
SECONDARY outcome
Timeframe: 30 days post-treatment, up to 32 monthsThe number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.
Outcome measures
| Measure |
Enzalutamide
n=46 Participants
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0
|
22 Participants
|
Adverse Events
Enzalutamide
Serious events: 15 serious events
Other events: 44 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Enzalutamide
n=46 participants at risk
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Cardiac disorders
Heart failure
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Cardiac disorders
Myocardial infarction
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Infections and infestations
Bone infection
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Infections and infestations
Infections and infestations - Oth spec
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Infections and infestations
Sepsis
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Alkaline phosphatase increased
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Edema cerebral
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Stroke
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Insomnia
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
2/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
Other adverse events
| Measure |
Enzalutamide
n=46 participants at risk
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
23.9%
11/46 • Number of events 22 • Up to 30 days post-treatment, up to 32 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.2%
1/46 • Number of events 12 • Up to 30 days post-treatment, up to 32 months
|
|
Cardiac disorders
Heart failure
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Ear and labyrinth disorders
Ear pain
|
4.3%
2/46 • Number of events 5 • Up to 30 days post-treatment, up to 32 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Eye disorders
Blurred vision
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Eye disorders
Dry eye
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Eye disorders
Eye disorders - Other, specify
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Constipation
|
15.2%
7/46 • Number of events 32 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Dental caries
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Diarrhea
|
28.3%
13/46 • Number of events 36 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
4/46 • Number of events 22 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
3/46 • Number of events 22 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.5%
3/46 • Number of events 8 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Nausea
|
17.4%
8/46 • Number of events 13 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Oral pain
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
5/46 • Number of events 7 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Edema limbs
|
4.3%
2/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Facial pain
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Fatigue
|
87.0%
40/46 • Number of events 205 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Fever
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
6.5%
3/46 • Number of events 8 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Localized edema
|
19.6%
9/46 • Number of events 22 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Neck edema
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Non-cardiac chest pain
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
General disorders
Pain
|
13.0%
6/46 • Number of events 24 • Up to 30 days post-treatment, up to 32 months
|
|
Infections and infestations
Gum infection
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
3/46 • Number of events 5 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Alkaline phosphatase increased
|
10.9%
5/46 • Number of events 9 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
6/46 • Number of events 14 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Blood bilirubin increased
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Creatinine increased
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Investigations - Other, specify
|
2.2%
1/46 • Number of events 20 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Lymphocyte count decreased
|
17.4%
8/46 • Number of events 25 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Neutrophil count decreased
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Platelet count decreased
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Weight gain
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
Weight loss
|
45.7%
21/46 • Number of events 44 • Up to 30 days post-treatment, up to 32 months
|
|
Investigations
White blood cell decreased
|
10.9%
5/46 • Number of events 10 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Anorexia
|
21.7%
10/46 • Number of events 37 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.2%
7/46 • Number of events 26 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.3%
2/46 • Number of events 5 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.3%
2/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
2/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.7%
4/46 • Number of events 7 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.7%
4/46 • Number of events 6 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
1/46 • Number of events 7 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.9%
5/46 • Number of events 9 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.5%
3/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.3%
2/46 • Number of events 5 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
4.3%
2/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
4.3%
2/46 • Number of events 10 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.7%
4/46 • Number of events 17 • Up to 30 days post-treatment, up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.0%
6/46 • Number of events 12 • Up to 30 days post-treatment, up to 32 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Dizziness
|
28.3%
13/46 • Number of events 41 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Dysgeusia
|
6.5%
3/46 • Number of events 24 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Dysphasia
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Facial nerve disorder
|
4.3%
2/46 • Number of events 7 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Headache
|
6.5%
3/46 • Number of events 11 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Paresthesia
|
6.5%
3/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.3%
2/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Seizure
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Nervous system disorders
Tremor
|
4.3%
2/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Anxiety
|
4.3%
2/46 • Number of events 7 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Depression
|
4.3%
2/46 • Number of events 6 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Hallucinations
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Insomnia
|
17.4%
8/46 • Number of events 30 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Libido decreased
|
2.2%
1/46 • Number of events 6 • Up to 30 days post-treatment, up to 32 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Reproductive system and breast disorders
Breast pain
|
21.7%
10/46 • Number of events 72 • Up to 30 days post-treatment, up to 32 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
17.4%
8/46 • Number of events 67 • Up to 30 days post-treatment, up to 32 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.3%
2/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
6/46 • Number of events 12 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.0%
6/46 • Number of events 13 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.3%
2/46 • Number of events 5 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.2%
1/46 • Number of events 4 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.3%
2/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46 • Number of events 28 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
2/46 • Number of events 9 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.5%
3/46 • Number of events 8 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
1/46 • Number of events 2 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
4.3%
2/46 • Number of events 3 • Up to 30 days post-treatment, up to 32 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
|
Vascular disorders
Hot flashes
|
47.8%
22/46 • Number of events 123 • Up to 30 days post-treatment, up to 32 months
|
|
Vascular disorders
Hypertension
|
73.9%
34/46 • Number of events 207 • Up to 30 days post-treatment, up to 32 months
|
|
Vascular disorders
Hypotension
|
2.2%
1/46 • Number of events 1 • Up to 30 days post-treatment, up to 32 months
|
Additional Information
Alan Ho, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4235
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place