Trial Outcomes & Findings for Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma (NCT NCT02631590)
NCT ID: NCT02631590
Last Updated: 2021-08-04
Results Overview
PFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
6 months
Results posted on
2021-08-04
Participant Flow
Participant milestones
| Measure |
Combination Therapy
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma
Baseline characteristics by cohort
| Measure |
Combination Therapy
n=24 Participants
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 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
|
1 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 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
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPFS at six months. Response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1). PFS will be calculated from study entry to documented disease progression, death from any cause, or date of last follow-up, whichever comes first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)
Outcome measures
| Measure |
Combination Therapy
n=24 Participants
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Progression Free Survival (PFS)
|
6.2 months
Interval 2.9 to 10.1
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Number of participants evaluable for response
Complete Response + Partial Response according to RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Combination Therapy
n=19 Participants
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Response Rate
Partial Response
|
31.6 percentage of participants
|
|
Response Rate
Stable Disease
|
57.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Outcome measures
| Measure |
Combination Therapy
n=24 Participants
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Overall Survival (OS)
|
13.7 months
Interval 6.8 to 18.0
|
Adverse Events
Combination Therapy
Serious events: 12 serious events
Other events: 24 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Combination Therapy
n=24 participants at risk
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Ascites
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Colitis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Colonic obstruction
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders -Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Edema limbs
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Fatigue
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Pain
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Hepatobiliary disorders
Hepatic infection
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Infections and Infestations - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Lung infection
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Sepsis
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Blood bilirubin increased
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Platelet count decreased
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Vascular disorders
Thromboembolic event
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
Other adverse events
| Measure |
Combination Therapy
n=24 participants at risk
Treatment Plan: Cisplatin (25 mg/m\^2 ) + Gemcitabine (1000 mg/m\^2) + copanlisib (60 mg) on days 1 and 8 with day 15 off to be administered on an every 21-days schedule.
Cisplatin: Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
Gemcitabine: Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
Copanlisib: Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
50.0%
12/24 • Number of events 22 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Diarrhea
|
45.8%
11/24 • Number of events 12 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
41.7%
10/24 • Number of events 13 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
6/24 • Number of events 7 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
6/24 • Number of events 13 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
12.5%
3/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
2/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Ascites
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Bloating
|
8.3%
2/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
2/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Colitis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Colonic obstruction
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Pancreatitis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Stomach pain
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Gastrointestinal disorders
Toothache
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Fatigue
|
70.8%
17/24 • Number of events 27 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Fever
|
33.3%
8/24 • Number of events 24 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Edema limbs
|
20.8%
5/24 • Number of events 6 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Chills
|
16.7%
4/24 • Number of events 7 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Pain
|
16.7%
4/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Infusion related reaction
|
12.5%
3/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
3/24 • Number of events 6 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
General disorders and administration site conditions -Other
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Gait disturbance
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Infusion site extravasation
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
General disorders
Malaise
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Lymphocyte count decreased
|
75.0%
18/24 • Number of events 66 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Platelet count decreased
|
75.0%
18/24 • Number of events 45 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
White blood cell decreased
|
70.8%
17/24 • Number of events 72 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Neutrophil count decreased
|
66.7%
16/24 • Number of events 62 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Lipase increased
|
45.8%
11/24 • Number of events 33 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Alanine aminotransferase increased
|
41.7%
10/24 • Number of events 21 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Weight loss
|
25.0%
6/24 • Number of events 15 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Aspartate aminotransferase increased
|
20.8%
5/24 • Number of events 15 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Serum amylase increased
|
20.8%
5/24 • Number of events 9 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
4/24 • Number of events 8 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Creatinine increased
|
16.7%
4/24 • Number of events 5 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Blood bilirubin increased
|
12.5%
3/24 • Number of events 6 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Blood antidiuretic hormone abnormal
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Investigations - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Investigations
Urine output decreased
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
54.2%
13/24 • Number of events 43 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
45.8%
11/24 • Number of events 14 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
29.2%
7/24 • Number of events 10 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
6/24 • Number of events 6 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
6/24 • Number of events 8 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
3/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
16/24 • Number of events 56 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Vascular disorders
Hypertension
|
62.5%
15/24 • Number of events 54 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Vascular disorders
Hypotension
|
25.0%
6/24 • Number of events 8 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Vascular disorders
Thromboembolic event
|
16.7%
4/24 • Number of events 9 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Vascular disorders
Phlebitis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
3/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
2/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
6/24 • Number of events 15 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
8.3%
2/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Nervous system disorders
Dizziness
|
16.7%
4/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Nervous system disorders
Dysgeusia
|
8.3%
2/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
2/24 • Number of events 5 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Nervous system disorders
Parathesia
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Sepsis
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
3/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Infections and infestations - Other
|
8.3%
2/24 • Number of events 5 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Gallbladder infection
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Infections and infestations
Hepatic infection
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
4/24 • Number of events 4 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Cardiac disorders
Paroxysmal atrial tachycardia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Cardiac disorders
Pericarditis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Cardiac disorders
Sinus bradycardia
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Psychiatric disorders
Anxiety
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Psychiatric disorders
Depression
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Psychiatric disorders
Insomnia
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Psychiatric disorders
Confusion
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Renal and urinary disorders
Cystitis noninfective
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Renal and urinary disorders
Hematuria
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Renal and urinary disorders
Urine discoloration
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
12.5%
3/24 • Number of events 3 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Ear and labyrinth disorders
Ear pain
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
8.3%
2/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Eye disorders
Cataract
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Eye disorders
Dry eye
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.2%
1/24 • Number of events 2 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Injury, poisoning and procedural complications
Venous injury
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Immune system disorders
Allergic reaction
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
4.2%
1/24 • Number of events 1 • All adverse events collected from start of study drug to 4 weeks after end of treatment, 2 years 3 months.
|
Additional Information
Richard Kim, MD, Principal Investigator
Moffitt Cancer Center
Phone: 813-745-1277
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place