Trial Outcomes & Findings for Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors (NCT NCT02575300)
NCT ID: NCT02575300
Last Updated: 2020-09-11
Results Overview
Response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For this study, measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: 10 mm by CT scan (CT scan slice thickness no greater than 5 mm (when CT scans have slice thickness \>5 mm, the minimum size should be twice the slice thickness); 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable); 20 mm by chest X-ray. Complete Response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2020-09-11
Participant Flow
Participant milestones
| Measure |
Ibrutinib Therapy
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
Ibrutinib Therapy
n=20 Participants
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsPopulation: All participants who received at least one dose of study drug.
Response rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. For this study, measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of: 10 mm by CT scan (CT scan slice thickness no greater than 5 mm (when CT scans have slice thickness \>5 mm, the minimum size should be twice the slice thickness); 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable); 20 mm by chest X-ray. Complete Response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Ibrutinib Therapy
n=20 Participants
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Radiographic Response Rate (ORR)
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearProgression free survival at one year. PFS, determined as the time from administration of the initial dose of ibrutinib until objective tumor progression using RECIST, or death. Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Ibrutinib Therapy
n=20 Participants
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Progression Free Survival (PFS)
|
3.0 months
Interval 2.8 to 5.8
|
SECONDARY outcome
Timeframe: Up to 24 monthsOverall Survival determined from the time of drug administration to death from any cause.
Outcome measures
| Measure |
Ibrutinib Therapy
n=20 Participants
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Survival (OS)
|
24.1 months
Interval 16.5 to
The high end of the range was not reached at time of analysis.
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: All participants who received at least one dose of study drug and had at least one adverse event that was possibly probably or definitely related to study treatment.
Adverse events possibly related to study treatment with Ibrutinib. Safety and tolerability will be assessed according to the NIH/NCI Common TerminologyCriteria for Adverse Events version 4 (CTCAE v4).
Outcome measures
| Measure |
Ibrutinib Therapy
n=20 Participants
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Occurrence of Possibly Related Adverse Events (AEs)
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsPopulation: No participants experienced objective response
Duration of response, defined as time from first observation of an objective response which is subsequently confirmed, to first disease progression or death due to any cause.
Outcome measures
Outcome data not reported
Adverse Events
Ibrutinib Therapy
Serious events: 2 serious events
Other events: 20 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Ibrutinib Therapy
n=20 participants at risk
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
Other adverse events
| Measure |
Ibrutinib Therapy
n=20 participants at risk
Ibrutinib Initial Dose 560 mg by mouth (PO) every day (QD)
Ibrutinib: Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders-other
|
10.0%
2/20 • Number of events 5 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
5/20 • Number of events 5 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Vascular disorders
Flushing
|
15.0%
3/20 • Number of events 4 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 5 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Eye disorders
Cataracts
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
8/20 • Number of events 17 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
2/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Constipation
|
15.0%
3/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
11/20 • Number of events 28 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
15.0%
3/20 • Number of events 7 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
30.0%
6/20 • Number of events 9 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorders, other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders, other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20 • Number of events 26 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Stomach Pain
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
4/20 • Number of events 13 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Chills
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Edema limbs
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Fatigue
|
55.0%
11/20 • Number of events 17 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Irritability
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Neck edema
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
Pain
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Immune system disorders
Anaphylaxis
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Infections and infestations
Sinusitis
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Infections and infestations
Upper respiratory infection
|
15.0%
3/20 • Number of events 5 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Injury, poisoning and procedural complications
Bruising
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • Number of events 9 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Number of events 4 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Investigations
Lymphocyte count decreased
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Investigations
Weight loss
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
15.0%
3/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.0%
3/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.0%
7/20 • Number of events 12 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
4/20 • Number of events 11 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.0%
3/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • Number of events 8 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Dysphasia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • Number of events 5 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Memory impairment
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Parasethesia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Psychiatric disorders
Agitation
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
2/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Renal and urinary disorders
Urinary tract pain
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.0%
3/20 • Number of events 3 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Vascular disorders
Hot flashes
|
5.0%
1/20 • Number of events 2 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Vascular disorders
Hypertension
|
20.0%
4/20 • Number of events 8 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
General disorders
General disorders and administration site conditions - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders -Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders - Other
|
5.0%
1/20 • Number of events 1 • 3 years, 5 months
SAEs are reported that occurred after first dose of study drug through 30 days after discontinuation of study drug.
|
Additional Information
Dr. Jonathan Strosberg, MD
H. Lee Moffitt Cancer and Research Center
Phone: 813-745-7257
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place