Trial Outcomes & Findings for Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases (NCT NCT01934894)

NCT ID: NCT01934894

Last Updated: 2017-07-02

Results Overview

The number of patients with Complete and Partial Response (CR+PR) of CNS lesions assessed per modified RECIST Criteria for Evaluation of Intracranial Disease. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year

Results posted on

2017-07-02

Participant Flow

Between May 2014 and July 2015, 11 subjects with HER2-positive metastatic breast cancer and central nervous system (CNS) metastases were enrolled at 4 investigational sites in the U.S. The study was designed to define the optimal dose of study drugs to administer to subjects, then further assess intracranial response.

Participant milestones

Participant milestones
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (Level 1 (25 mg/m^2 Cabazitaxel + Lapatinib) Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Overall Study STARTED	6	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (Level 1 (25 mg/m^2 Cabazitaxel + Lapatinib) Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Overall Study Adverse Event	1	2
Overall Study Death	2	0
Overall Study Withdrawal by Subject	0	1
Overall Study Progressive Disease	3	2

Baseline Characteristics

Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 (20 mg/m2 Cabazitaxel + Lapatinib) n=6 Participants Cabazitaxel: 20 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (Level 1 (25 mg/m2 Cabazitaxel + Lapatinib) n=5 Participants Cabazitaxel: 25 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Total n=11 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	60 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year

Population: Includes all treated participants

Outcome measures

Outcome measures
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=6 Participants Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) n=5 Participants Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
CNS Objective Response	0 Participants	0 Participants

PRIMARY outcome

Timeframe: weekly for 3 weeks

Population: Includes all treated participants, either at Dose Level 1 or Dose Level 2

The maximum tolerated dose (MTD) of cabazitaxel and lapatinib will be determined as the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0. A listing of DLTs are reported in the subsequent Primary Outcome Measure.

Outcome measures

Outcome measures
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=11 Participants Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Maximum Tolerated Dose of Cabazitaxel With Lapatinib	NA mg/m^2 of cabazitaxel + lapatinib The MTD was not reached. Due to DLTs and other observed toxicities, a decision was made to close the study early.	—

PRIMARY outcome

Timeframe: weekly for 3 weeks

During the safety lead-in, a standard 3+3 dose escalation design is used to determine the maximum tolerated dose (MTD) of cabazitaxel with lapatinib. The MTD would be determined by the highest dose at which ≤1 of 6 patients experiences a dose-limiting toxicity (DLT) during 1 cycle (21 days) of therapy. If 2 of 6 patients within a dose level experiences a DLT, that dose level would be defined as exceeding the MTD and the previous dose level would be evaluated. DLTs are assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.

Outcome measures

Outcome measures
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=6 Participants Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) n=5 Participants Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety febrile neutropenia	0 Participants	1 Participants
Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety neutropenia	0 Participants	1 Participants
Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety diarrhea	0 Participants	2 Participants
Number of Participants Who Experience Dose-Limiting Toxicities (DLTs) as a Measure of Safety septic shock	1 Participants	0 Participants

SECONDARY outcome

Timeframe: every 6 weeks thru cycle 8, and every 3 cycles thereafter until treatment discontinuation, projected 1 year

The number of patients with Complete Response, Partial Response or Stable Disease extending beyond 6 months (CR+PR+SD ≥ 6 months), determined by RECIST v1.1. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion; SD=Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.

Outcome measures

Outcome measures
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=6 Participants Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) n=5 Participants Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
CNS Clinical Benefit Response	2 Participants	0 Participants

SECONDARY outcome

Timeframe: every 6 weeks for 8 cycles, then every 9 weeks until treatment discontinuation, up to 1 year

The number of participants having Complete and Partial Responses (CR+PR) of extra-cranial lesions assessed per RECIST v1.1 Criteria. CR=disappearance of all target and non-target lesions; PR=at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.

Outcome measures

Outcome measures
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=6 Participants Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) n=5 Participants Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Extra-Cranial Objective Response	0 Participants	0 Participants

SECONDARY outcome

Timeframe: every 6 weeks thru cycle 8, then every 9 weeks until treatment discontinuation, projected 1 year

Population: No data was collected for this outcome measure.

Evaluate the three and six-month CNS progression free survival measured from date of first protocol treatment until tumor progression or death.

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=6 participants at risk Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) n=5 participants at risk Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Number of events 1 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Number of events 1 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
General disorders DEATH	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Infections and infestations SEPTIC SHOCK	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.

Other adverse events

Additional Information

Charles Davis, RAC

SCRI Development Innovations

Phone: 615-524-4341

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib) n=6 participants at risk Cabazitaxel: 20 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily	Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib) n=5 participants at risk Cabazitaxel: 25 mg/m\^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
Gastrointestinal disorders DIARRHOEA	83.3% 5/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	80.0% 4/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
General disorders FATIGUE	33.3% 2/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Gastrointestinal disorders NAUSEA	33.3% 2/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Nervous system disorders BALANCE DISORDER	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Investigations BLOOD BILIRUBIN INCREASED	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Gastrointestinal disorders CONSTIPATION	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Skin and subcutaneous tissue disorders DRY SKIN	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Gastrointestinal disorders HAEMORRHOIDS	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Nervous system disorders HEADACHE	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Vascular disorders HOT FLUSH	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Metabolism and nutrition disorders HYPERCALCAEMIA	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Metabolism and nutrition disorders HYPERGLYCAEMIA	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Metabolism and nutrition disorders HYPOKALAEMIA	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Blood and lymphatic system disorders LEUKOPENIA	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Infections and infestations LOCALISED INFECTION	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Respiratory, thoracic and mediastinal disorders NASAL ULCER	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
General disorders OEDEMA PERIPHERAL	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Skin and subcutaneous tissue disorders ONYCHOCLASIS	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Skin and subcutaneous tissue disorders PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Skin and subcutaneous tissue disorders RASH	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Immune system disorders SEASONAL ALLERGY	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Infections and infestations URINARY TRACT INFECTION	16.7% 1/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	0.00% 0/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Psychiatric disorders ANXIETY	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	40.0% 2/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Nervous system disorders DIZZINESS	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Nervous system disorders DYSGEUSIA	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	20.0% 1/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/6 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.	40.0% 2/5 • Every 3 weeks for approximately 6 months Adverse events (AEs) were collected for all patients who received at least 1 dose of treatment - from date of first treatment through the 30-day end of treatment period. All patients had at least one AE.