Trial Outcomes & Findings for Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer (NCT NCT03121352)
NCT ID: NCT03121352
Last Updated: 2023-10-06
Results Overview
The number of people with tumor responses according to RECIST (V1.1). These responses include 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 diameters of target lesions, taking as reference the baseline sum diameters. 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 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). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2023-10-06
Participant Flow
Participant milestones
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=30 Participants
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Age, Customized
30-39 years
|
2 participants
n=113 Participants
|
|
Age, Customized
40-49 years
|
7 participants
n=113 Participants
|
|
Age, Customized
50-59 years
|
11 participants
n=113 Participants
|
|
Age, Customized
60-69 years
|
4 participants
n=113 Participants
|
|
Age, Customized
70-79 years
|
5 participants
n=113 Participants
|
|
Age, Customized
80-89 years
|
1 participants
n=113 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=113 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=113 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsPopulation: All participants who were evaluable for clinical response. Three participants were not evaluable for treatment response per Principal Investigator's assessment
The number of people with tumor responses according to RECIST (V1.1). These responses include 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 diameters of target lesions, taking as reference the baseline sum diameters. 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 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). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcome measures
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=27 Participants
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Overall Response Rate (ORR) in Patients Treated With CNP
Complete Response (CR)
|
2 Participants
|
|
Overall Response Rate (ORR) in Patients Treated With CNP
Partial Response (PR)
|
11 Participants
|
|
Overall Response Rate (ORR) in Patients Treated With CNP
Progressive Disease (PD)
|
6 Participants
|
|
Overall Response Rate (ORR) in Patients Treated With CNP
Stable Disease (SD)
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All participants who received treatment.
Average time (in months) patient's tumors did not progress according to the RECIST criteria (V1.1). Progressive disease is defined as 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 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
Outcome measures
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=30 Participants
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Progression-free Survival (PFS) in Patients Treated With CNP
|
5.8 months
Interval 4.7 to 8.5
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: All participants who were evaluable for clinical response. Three participants were not evaluable for treatment response per Principal Investigator's assessment
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention. Responses are defined as 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 or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcome measures
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=27 Participants
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Disease Control Rate (DCR) in Patients Treated With CNP
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: Participants who have a CR and PR response from treatment
Average time patients have a response, as defined by the RECIST criteria (V1.1). Response includes: 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 or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=13 Participants
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Duration of Response in Patients Treated With CNP
Complete
|
NA Months
The median duration for complete response was not reached. The two patients who had a complete response never progressed during the entire time of the study, and therefore, their response was ongoing at the time of the data analysis.
|
|
Duration of Response in Patients Treated With CNP
Partial
|
6.3 Months
Interval 3.0 to 7.0
|
Adverse Events
Carboplatin + Nab-paclitaxel + Pembrolizumab
Serious events: 13 serious events
Other events: 30 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=30 participants at risk
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Severe Left Thigh Pain Due to a Hematoma
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Creatinine increased
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Breast infection
|
3.3%
1/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
General disorders
Fever
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Blood and lymphatic system disorders
INR increased
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Immune system disorders
Autoimmune disorder-hepatitis
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Lung infection (pneumonia)
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Urinary tract infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
3/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Device related infection
|
3.3%
1/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Soft tissue infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
6.7%
2/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
General disorders
Death due to disease progression
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Non-cardiac chest pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Psychiatric disorders
Psychosis-altered mental status
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Infection
|
3.3%
1/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Immune system disorders
Allergic reaction
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized pain-hip and lower extremities
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
Other adverse events
| Measure |
Carboplatin + Nab-paclitaxel + Pembrolizumab
n=30 participants at risk
Combination therapy of Carboplatin, Nab-paclitaxel, and Pembrolizumab
Carboplatin: AUC 4.5 IV day 1 of 21-day cycle
Nab-paclitaxel: 75mg/m2 IV days 1, 8 and 15 of 21-day cycle
Pembrolizumab: 200 mg IV every 21 days
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
3/30 • Number of events 6 • Up to five years after cycle six of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
3.3%
1/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Investigations
Alanine aminotransferase increased
|
26.7%
8/30 • Number of events 19 • Up to five years after cycle six of treatment
|
|
Investigations
Alkaline phosphatase increased
|
13.3%
4/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Immune system disorders
Allergic reaction
|
6.7%
2/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
13.3%
4/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
20/30 • Number of events 39 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Anal pain
|
3.3%
1/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
70.0%
21/30 • Number of events 109 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
15/30 • Number of events 25 • Up to five years after cycle six of treatment
|
|
Psychiatric disorders
Anxiety
|
20.0%
6/30 • Number of events 13 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
2/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
6/30 • Number of events 19 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Ataxia
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
3/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Bloating
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Blood and lymphatic system disorders
Iron Deficiency
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Blood bilirubin increased
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Eye disorders
Blurred vision
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Breast infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
5/30 • Number of events 6 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Bronchial infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Carbon monoxide diffusing capacity decreased
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Psychiatric disorders
Confusion
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Constipation
|
43.3%
13/30 • Number of events 19 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
9/30 • Number of events 15 • Up to five years after cycle six of treatment
|
|
Investigations
Creatinine increased
|
13.3%
4/30 • Number of events 15 • Up to five years after cycle six of treatment
|
|
General disorders
Death NOS
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
3/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Psychiatric disorders
Depression
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
18/30 • Number of events 38 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Dizziness
|
23.3%
7/30 • Number of events 11 • Up to five years after cycle six of treatment
|
|
Eye disorders
Dry eye
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
3/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
3/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Dysgeusia
|
33.3%
10/30 • Number of events 13 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • Number of events 6 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Dysphasia
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
9/30 • Number of events 18 • Up to five years after cycle six of treatment
|
|
General disorders
Edema limbs
|
20.0%
6/30 • Number of events 7 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
3/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
3.3%
1/30 • Number of events 6 • Up to five years after cycle six of treatment
|
|
Eye disorders
Blood shot eyes, capillary ruptures intermittently
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Eye disorders
Aura, intermittent
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Eye disorders
Scleral disease
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Eye disorders
Visitoin - aura (intermittent)
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Eye disorders
Red sclera
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Facial muscle weakness
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Facial pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
3/30 • Number of events 7 • Up to five years after cycle six of treatment
|
|
General disorders
Fatigue
|
56.7%
17/30 • Number of events 56 • Up to five years after cycle six of treatment
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Flu like symptoms
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Vascular disorders
Flushing
|
6.7%
2/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Broken tooth
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Heartburn
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Elevated Vitamin D
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
23.3%
7/30 • Number of events 17 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Gingival pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Headache
|
20.0%
6/30 • Number of events 8 • Up to five years after cycle six of treatment
|
|
Vascular disorders
Hot flashes
|
16.7%
5/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
3/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
3/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
10.0%
3/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Vascular disorders
Hypertension
|
20.0%
6/30 • Number of events 12 • Up to five years after cycle six of treatment
|
|
Endocrine disorders
Hyperthyroidism
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
23.3%
7/30 • Number of events 7 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
2/30 • Number of events 10 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
30.0%
9/30 • Number of events 23 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
43.3%
13/30 • Number of events 30 • Up to five years after cycle six of treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.3%
7/30 • Number of events 12 • Up to five years after cycle six of treatment
|
|
Vascular disorders
Hypotension
|
13.3%
4/30 • Number of events 6 • Up to five years after cycle six of treatment
|
|
Endocrine disorders
Hypothyroidism
|
23.3%
7/30 • Number of events 7 • Up to five years after cycle six of treatment
|
|
Immune system disorders
Immune related hepatitis
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Infection-other
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Infusion related reaction
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Psychiatric disorders
Insomnia
|
13.3%
4/30 • Number of events 9 • Up to five years after cycle six of treatment
|
|
Vascular disorders
Lymphedema
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Lymphocyte count decreased
|
36.7%
11/30 • Number of events 65 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
13.3%
4/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
3/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
10.0%
3/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Nail infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Nausea
|
66.7%
20/30 • Number of events 42 • Up to five years after cycle six of treatment
|
|
General disorders
Neck edema
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Aura, intermittent
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Heat sensation, lower right back
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Neutrophil count decreased
|
66.7%
20/30 • Number of events 91 • Up to five years after cycle six of treatment
|
|
General disorders
Non-cardiac chest pain
|
13.3%
4/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Otitis media
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
General disorders
Pain
|
30.0%
9/30 • Number of events 10 • Up to five years after cycle six of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
3/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Papulopustular rash
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
40.0%
12/30 • Number of events 27 • Up to five years after cycle six of treatment
|
|
Investigations
Platelet count decreased
|
50.0%
15/30 • Number of events 54 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
4/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.3%
1/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Presyncope
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.7%
2/30 • Number of events 3 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
3/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Psychiatric disorders
Psychosis
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Rash pustular
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
6/30 • Number of events 6 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Sinusitis
|
10.0%
3/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Blistering, left leg
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Facial redness/bumpy/moon face
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
10.0%
3/30 • Number of events 4 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Spasticity
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Syncope
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Tooth infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Nervous system disorders
Tremor
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
2/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Renal and urinary disorders
Urinary frequency
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Urinary tract infection
|
13.3%
4/30 • Number of events 5 • Up to five years after cycle six of treatment
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Number of events 2 • Up to five years after cycle six of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
9/30 • Number of events 12 • Up to five years after cycle six of treatment
|
|
Eye disorders
Watering eyes
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Weight gain
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
|
Investigations
Weight loss
|
23.3%
7/30 • Number of events 10 • Up to five years after cycle six of treatment
|
|
Investigations
White blood cell decreased
|
70.0%
21/30 • Number of events 137 • Up to five years after cycle six of treatment
|
|
Infections and infestations
Wound infection
|
3.3%
1/30 • Number of events 1 • Up to five years after cycle six of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place