Trial Outcomes & Findings for A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II) (NCT NCT01100931)
NCT ID: NCT01100931
Last Updated: 2015-10-19
Results Overview
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
1 year
Results posted on
2015-10-19
Participant Flow
One patient withdrew consent before starting treatment.
Participant milestones
| Measure |
Phase I
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
|---|---|---|
|
Phase I
STARTED
|
22
|
0
|
|
Phase I
COMPLETED
|
22
|
0
|
|
Phase I
NOT COMPLETED
|
0
|
0
|
|
Phase II
STARTED
|
0
|
19
|
|
Phase II
COMPLETED
|
0
|
19
|
|
Phase II
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase I/II Study of Paclitaxel, Carboplatin and YM155 (Survivin Suppressor) in Subjects With Solid Tumors (Phase I) and Advanced Non-Small Cell Lung Carcinoma (Phase II)
Baseline characteristics by cohort
| Measure |
Phase I
n=22 Participants
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
n=19 Participants
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.51 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
19 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Phase I dose was variable dosing schedule to determine maximum tolerated dose (MTD) with 22 patients analyzed. Dose was variable with MTD at 10mg/m\^2.
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days). Phase 2 dose is based upon dose limiting toxicities experienced during cycle 1.
Outcome measures
| Measure |
Phase I
n=22 Participants
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
|---|---|---|
|
Phase 1 Safe and Tolerable Phase 2 Dose.
|
10 mg/m^2
|
—
|
PRIMARY outcome
Timeframe: up to 18 weeksPopulation: Phase I is not included here because this outcome measure is for phase II only.
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is the 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) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase I
n=19 Participants
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
|---|---|---|
|
Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).
Complete Response
|
0 Participants
|
—
|
|
Phase 2 Objective Response Rate (Partial Response (PR) + Complete Response (CR)).
Partial Response
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: 31.5 monthsHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Phase I
n=22 Participants
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
n=19 Participants
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
22 Participants
|
19 Participants
|
Adverse Events
Phase I
Serious events: 10 serious events
Other events: 22 other events
Deaths: 0 deaths
Phase II
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I
n=22 participants at risk
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
n=19 participants at risk
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
|---|---|---|
|
General disorders
Death NOS
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Enterocolitis infectious
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
General disorders
Fever
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Flu like symptoms
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Neutrophil count decreased
|
18.2%
4/22 • Number of events 4
|
0.00%
0/19
|
|
Gastrointestinal disorders
Pancreatitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Seizure
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Sepsis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Stroke
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Nervous system disorders
Syncope
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Mucosal infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Platelet count decreased
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
Other adverse events
| Measure |
Phase I
n=22 participants at risk
Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m\^2, dose level 2:5 mg/m\^2 , dose level 3:6 mg/m\^2, dose level 4:8 mg/m\^2, dose level 5:10 mg/m\^2 (MTD), dose level 6:12 mg/m\^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
|
Phase II
n=19 participants at risk
Phase II: 10 mg/m\^2 (MTD)intravenous infusion over 72 hours every 21 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
4/22 • Number of events 5
|
0.00%
0/19
|
|
Investigations
Activated partial thromboplastin time prolonged
|
31.8%
7/22 • Number of events 11
|
0.00%
0/19
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Agitation
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
27.3%
6/22 • Number of events 20
|
0.00%
0/19
|
|
Investigations
Alkaline phosphatase increased
|
22.7%
5/22 • Number of events 12
|
5.3%
1/19 • Number of events 1
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/22
|
15.8%
3/19 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
63.6%
14/22 • Number of events 14
|
84.2%
16/19 • Number of events 16
|
|
Blood and lymphatic system disorders
Anemia
|
72.7%
16/22 • Number of events 61
|
36.8%
7/19 • Number of events 14
|
|
Metabolism and nutrition disorders
Anorexia
|
40.9%
9/22 • Number of events 9
|
15.8%
3/19 • Number of events 3
|
|
Psychiatric disorders
Anxiety
|
9.1%
2/22 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.6%
3/22 • Number of events 3
|
31.6%
6/19 • Number of events 6
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
6/22 • Number of events 15
|
0.00%
0/19
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Bloating
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Blood bilirubin increased
|
13.6%
3/22 • Number of events 4
|
0.00%
0/19
|
|
Eye disorders
Blurred vision
|
4.5%
1/22 • Number of events 1
|
21.1%
4/19 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.6%
3/22 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
|
Infections and infestations
Bronchial infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
9.1%
2/22 • Number of events 3
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Cardiac disorders
Chest pain - cardiac
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Chills
|
4.5%
1/22 • Number of events 2
|
0.00%
0/19
|
|
Nervous system disorders
Cognitive disturbance
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Eye disorders
Conjunctivitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Constipation
|
40.9%
9/22 • Number of events 9
|
47.4%
9/19 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
5/22 • Number of events 5
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Creatinine increased
|
31.8%
7/22 • Number of events 11
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
2/22 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Depression
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
2/22 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Number of events 4
|
21.1%
4/19 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
1/22 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
9.1%
2/22 • Number of events 3
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Dysphagia
|
18.2%
4/22 • Number of events 5
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.6%
3/22 • Number of events 4
|
31.6%
6/19 • Number of events 6
|
|
General disorders
Edema face
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Edema limbs
|
13.6%
3/22 • Number of events 5
|
10.5%
2/19 • Number of events 2
|
|
Investigations
Electrocardiogram QT corrected interval prolong
|
13.6%
3/22 • Number of events 3
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Esophageal pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Esophagitis
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Eye disorders
Eye infection
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
General disorders
Fatigue
|
45.5%
10/22 • Number of events 13
|
57.9%
11/19 • Number of events 12
|
|
General disorders
Fever
|
13.6%
3/22 • Number of events 3
|
0.00%
0/19
|
|
Gastrointestinal disorders
Flatulence
|
13.6%
3/22 • Number of events 3
|
0.00%
0/19
|
|
General disorders
Flu like symptoms
|
9.1%
2/22 • Number of events 4
|
21.1%
4/19 • Number of events 4
|
|
Vascular disorders
Flushing
|
9.1%
2/22 • Number of events 2
|
15.8%
3/19 • Number of events 3
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 3
|
36.8%
7/19 • Number of events 7
|
|
Ear and labyrinth disorders
Hearing impaired
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.5%
1/22 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Hot flashes
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.6%
3/22 • Number of events 3
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.2%
4/22 • Number of events 8
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
27.3%
6/22 • Number of events 8
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/22
|
5.3%
1/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
31.8%
7/22 • Number of events 17
|
21.1%
4/19 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.5%
1/22 • Number of events 2
|
5.3%
1/19 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypokalemia
|
27.3%
6/22 • Number of events 18
|
10.5%
2/19 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
72.7%
16/22 • Number of events 56
|
57.9%
11/19 • Number of events 14
|
|
Metabolism and nutrition disorders
Hyponatremia
|
54.5%
12/22 • Number of events 31
|
10.5%
2/19 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
63.6%
14/22 • Number of events 33
|
15.8%
3/19 • Number of events 7
|
|
Vascular disorders
Hypotension
|
18.2%
4/22 • Number of events 4
|
5.3%
1/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
27.3%
6/22 • Number of events 6
|
26.3%
5/19 • Number of events 5
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Lipase increased
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Lung infection
|
18.2%
4/22 • Number of events 5
|
0.00%
0/19
|
|
Investigations
Lymphocyte count decreased
|
90.9%
20/22 • Number of events 108
|
73.7%
14/19 • Number of events 47
|
|
Investigations
lymphocyte count increased
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
General disorders
Malaise
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
13.6%
3/22 • Number of events 3
|
0.00%
0/19
|
|
Gastrointestinal disorders
Mucositis Oral
|
4.5%
1/22 • Number of events 2
|
31.6%
6/19 • Number of events 7
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
9.1%
2/22 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
4.5%
1/22 • Number of events 2
|
0.00%
0/19
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.7%
5/22 • Number of events 5
|
21.1%
4/19 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
36.4%
8/22 • Number of events 8
|
47.4%
9/19 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Neutrophil count decreased
|
90.9%
20/22 • Number of events 49
|
68.4%
13/19 • Number of events 29
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
|
Gastrointestinal disorders
Oral hemorrhage
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
Ear and labyrinth disorders
Otitis media
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22
|
10.5%
2/19 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Paresthesia
|
18.2%
4/22 • Number of events 4
|
0.00%
0/19
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/22
|
15.8%
3/19 • Number of events 3
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
54.5%
12/22 • Number of events 16
|
89.5%
17/19 • Number of events 23
|
|
Vascular disorders
Phlebitis
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Investigations
Platelet count decreased
|
54.5%
12/22 • Number of events 37
|
15.8%
3/19 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
1/22 • Number of events 3
|
0.00%
0/19
|
|
Nervous system disorders
Presyncope
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.2%
4/22 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.2%
4/22 • Number of events 7
|
0.00%
0/19
|
|
Gastrointestinal disorders
Rectal pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
13.6%
3/22 • Number of events 3
|
10.5%
2/19 • Number of events 3
|
|
Infections and infestations
Skin infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.1%
2/22 • Number of events 2
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
2/22 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Superior vena cava syndrome
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
|
Nervous system disorders
Tremor
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
4.5%
1/22 • Number of events 1
|
15.8%
3/19 • Number of events 3
|
|
Infections and infestations
Urethral infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/19
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22 • Number of events 2
|
10.5%
2/19 • Number of events 2
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 2
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/22
|
5.3%
1/19 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.5%
1/22 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
4/22 • Number of events 4
|
36.8%
7/19 • Number of events 8
|
|
Investigations
Weight gain
|
9.1%
2/22 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
Investigations
Weight loss
|
13.6%
3/22 • Number of events 3
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/22
|
10.5%
2/19 • Number of events 3
|
|
Investigations
White blood cell decreased
|
90.9%
20/22 • Number of events 74
|
63.2%
12/19 • Number of events 29
|
Additional Information
Dr. Giuseppe Giaccone
National Cancer Institute, National Institutes of Health
Phone: 301-496-4916
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place