Trial Outcomes & Findings for Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer (NCT NCT02339558)

Last Updated: 2019-09-13

Results Overview

Confirmed response rate is defined as either a Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1. \> To be consider a CR, there must be a disappearance of all target lesions and each target lymph node must have reduction in short axis to \< 1.0 cm.\> \> To be considered a PR, at least a 30% decrease in PBSD (sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation) taking as reference the baseline value.\> \> The confirmed response rate is reported as the number of patients reporting a CR or PR divided by the total number of evaluable patients multiplied by 100 (reported as a percentage).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2019-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Nivolumab) Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	45
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Nivolumab) n=45 Participants Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment Singapore	21 participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
Region of Enrollment China	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: One patient was a protocol violation and was not included in this analysis.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=44 Participants Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Confirmed Response Rate (Complete Response or Partial Response) Based on RECIST Version 1.1	20.5 percentage of patients with a response Interval 9.8 to 35.3

SECONDARY outcome

Timeframe: Up to 3 years on treatment

Population: All patients that began protocol treatment are included in this analysis.

Adverse events were collected and recorded according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine adverse event patterns. For this outcome measure, we summarize the worst graded adverse event regardless of treatment attribution per patient. All reported adverse events are reported in the Adverse Events section of this report.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=45 Participants Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Adverse Events Grade 3 or higher	28 Participants
Adverse Events Grade 4 or higher	5 Participants
Adverse Events Grade 5	3 Participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Data was not collected to analyze this secondary endpoint.

The Immune Response Criteria (IRC) is a response criteria derived from the WHO criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: All patients that reported a CR or PR on treatment were included in this analysis.

Duration of response defined as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented, assessed according to RECIST version 1.1.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=9 Participants Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Duration of Response	9.3 months Interval 3.6 to 13.1

SECONDARY outcome

Timeframe: Time from registration to the first of either death due to any cause or progression, assessed up to 3 years

Population: One patient was ineligible for this endpoint due to a protocol violation.

Progression Free Survival is defined as the time from registration to the time of death or progression, whichever occurs first. The distribution of PFS will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=44 Participants Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (PFS) Based on RECIST Version 1.1	2.8 months Interval 1.8 to 7.4

SECONDARY outcome

Timeframe: Time from registration to death due to any cause, assessed up to 3 years

Population: One patient was ineligible for this analysis.

Overall survival is defined as the time from registration to the time of death. The distribution of survival time will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Nivolumab) n=44 Participants Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	17.1 months Interval 10.9 to Too few events were recorded to estimate the upper 95% confidence interval.

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 weeks of treatment

Plasma EBV DNA half-life during the first 6 weeks of treatment will be correlated with RECIST-response to nivolumab.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

PD-1 and PD-L1 expression will be associated with treatment outcomes. The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and up to 3 years

The Chi-Square (or Fisher's Exact test) will be used to assess the association of categorical clinical data with categorical biomarker data. Time-to-event clinical data (PFS, OS) will be correlated with biomarker data using Kaplan-Meier methodology and Cox regression models. Logistic regression models will also be used to predict binary clinical data with baseline biomarker data. Finally, graphical methods and descriptive statistics will be used to summarize the data as well.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 16 weeks

Graphical methods and descriptive statistics will be used.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Nivolumab)

Serious events: 21 serious events

Other events: 45 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Nivolumab) n=45 participants at risk Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Blood and lymphatic system disorders Hemolysis	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Endocrine disorders Hypothyroidism	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Eye disorders Papilledema	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Colitis	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Gastrointestinal pain	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Nausea	4.4% 2/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Rectal hemorrhage	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Vomiting	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Fatigue	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Fever	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Non-cardiac chest pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Lung infection	6.7% 3/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Sepsis	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Alanine aminotransferase increased	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Aspartate aminotransferase increased	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypercalcemia	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypoalbuminemia	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hyponatremia	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Back pain	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Bone pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Headache	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	2.2% 1/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Skin ulceration	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Vascular disorders Hypertension	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.

Other adverse events

Other adverse events
Measure	Treatment (Nivolumab) n=45 participants at risk Patients receive 3 mg/kg nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Respiratory, thoracic and mediastinal disorders Sore throat	4.4% 2/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Blood and lymphatic system disorders Anemia	17.8% 8/45 • Number of events 22 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Blood and lymphatic system disorders Hemolysis	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Blood and lymphatic system disorders Lymph node pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Cardiac disorders Cardiac disorders - Other, specify	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Cardiac disorders Pericardial effusion	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Cardiac disorders Sinus bradycardia	2.2% 1/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Cardiac disorders Sinus tachycardia	2.2% 1/45 • Number of events 12 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Ear and labyrinth disorders Ear pain	4.4% 2/45 • Number of events 6 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Ear and labyrinth disorders External ear pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Ear and labyrinth disorders Vertigo	6.7% 3/45 • Number of events 10 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Endocrine disorders Endocrine disorders - Other, specify	4.4% 2/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Endocrine disorders Hyperthyroidism	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Endocrine disorders Hypothyroidism	17.8% 8/45 • Number of events 26 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Eye disorders Blurred vision	4.4% 2/45 • Number of events 7 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Eye disorders Conjunctivitis	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Eye disorders Eye disorders - Other, specify	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Eye disorders Floaters	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Eye disorders Watering eyes	2.2% 1/45 • Number of events 13 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Abdominal distension	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Abdominal pain	13.3% 6/45 • Number of events 9 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Constipation	8.9% 4/45 • Number of events 20 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Diarrhea	15.6% 7/45 • Number of events 13 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Dry mouth	11.1% 5/45 • Number of events 21 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Dysphagia	4.4% 2/45 • Number of events 10 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Mucositis oral	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Nausea	20.0% 9/45 • Number of events 11 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Stomach pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Toothache	6.7% 3/45 • Number of events 5 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Gastrointestinal disorders Vomiting	15.6% 7/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Chills	8.9% 4/45 • Number of events 5 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Edema face	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Edema limbs	4.4% 2/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Fatigue	46.7% 21/45 • Number of events 79 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Fever	11.1% 5/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Flu like symptoms	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders General disorders and administration site conditions - Other, specify	6.7% 3/45 • Number of events 6 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Non-cardiac chest pain	6.7% 3/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
General disorders Pain	20.0% 9/45 • Number of events 18 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Infections and infestations - Other, specify	4.4% 2/45 • Number of events 7 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Lung infection	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Paronychia	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Rash pustular	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Sinusitis	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Upper respiratory infection	4.4% 2/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Urinary tract infection	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Infections and infestations Wound infection	2.2% 1/45 • Number of events 5 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Injury, poisoning and procedural complications Fall	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Alanine aminotransferase increased	11.1% 5/45 • Number of events 10 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Alkaline phosphatase increased	6.7% 3/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Aspartate aminotransferase increased	15.6% 7/45 • Number of events 22 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Blood bilirubin increased	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Creatinine increased	8.9% 4/45 • Number of events 10 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Investigations - Other, specify	6.7% 3/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Lipase increased	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Lymphocyte count decreased	13.3% 6/45 • Number of events 23 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Neutrophil count decreased	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Platelet count decreased	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Serum amylase increased	6.7% 3/45 • Number of events 9 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Weight gain	2.2% 1/45 • Number of events 16 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations Weight loss	13.3% 6/45 • Number of events 16 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Investigations White blood cell decreased	4.4% 2/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Anorexia	17.8% 8/45 • Number of events 21 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Dehydration	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypercalcemia	8.9% 4/45 • Number of events 6 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hyperglycemia	17.8% 8/45 • Number of events 31 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hyperkalemia	4.4% 2/45 • Number of events 6 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypermagnesemia	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypernatremia	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypoalbuminemia	15.6% 7/45 • Number of events 16 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypocalcemia	8.9% 4/45 • Number of events 6 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypoglycemia	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypokalemia	13.3% 6/45 • Number of events 11 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypomagnesemia	11.1% 5/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hyponatremia	24.4% 11/45 • Number of events 27 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Hypophosphatemia	4.4% 2/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Arthralgia	2.2% 1/45 • Number of events 7 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Back pain	4.4% 2/45 • Number of events 11 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Chest wall pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Flank pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	6.7% 3/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Myalgia	11.1% 5/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Neck pain	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Cognitive disturbance	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Dizziness	8.9% 4/45 • Number of events 8 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Headache	4.4% 2/45 • Number of events 5 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Nervous system disorders - Other, specify	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Paresthesia	4.4% 2/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Peripheral motor neuropathy	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Nervous system disorders Peripheral sensory neuropathy	6.7% 3/45 • Number of events 10 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Psychiatric disorders Anxiety	4.4% 2/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Psychiatric disorders Confusion	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Psychiatric disorders Insomnia	2.2% 1/45 • Number of events 10 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Renal and urinary disorders Urinary incontinence	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Renal and urinary disorders Urine discoloration	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Reproductive system and breast disorders Erectile dysfunction	2.2% 1/45 • Number of events 12 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Aspiration	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Cough	26.7% 12/45 • Number of events 21 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.9% 4/45 • Number of events 5 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Hoarseness	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.2% 1/45 • Number of events 18 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Postnasal drip	8.9% 4/45 • Number of events 4 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Productive cough	4.4% 2/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	8.9% 4/45 • Number of events 5 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Respiratory, thoracic and mediastinal disorders Wheezing	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Dry skin	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Erythema multiforme	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Pruritus	2.2% 1/45 • Number of events 2 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Rash acneiform	2.2% 1/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.4% 2/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.7% 3/45 • Number of events 6 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Skin and subcutaneous tissue disorders Skin hypopigmentation	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Surgical and medical procedures Surgical and medical procedures - Other, specify	2.2% 1/45 • Number of events 1 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Vascular disorders Hypertension	6.7% 3/45 • Number of events 33 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.
Vascular disorders Hypotension	6.7% 3/45 • Number of events 3 • Adverse events were recorded after every 28 day cycle, up to 42 cycles. Adverse events were recorded after every 28 day cycle, up to 42 cycles.

Additional Information

Brigette B.Y. Ma

Prince of Wales Hospital

Phone: (852) 26321042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60