Trial Outcomes & Findings for Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer (NCT NCT03246074)

Last Updated: 2024-10-24

Results Overview

The number of dose limiting toxicities (DLTs) at each dose level will be reported. All toxicities will be reported by type and grade using NCI CTCAE version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

First cycle (28 days) of treatment

Results posted on

2024-10-24

Participant Flow

35 participants were consented. 8 were screen failures. 27 were assigned to study arms.

Participant milestones

Participant milestones
Measure	Fostamatinib 100 mg Bid and Paclitaxel Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Overall Study STARTED	6	3	18
Overall Study COMPLETED	6	3	18
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial of Combined Fostamatinib and Paclitaxel in Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=6 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=18 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Total n=27 Participants Total of all reporting groups
Age, Continuous	62.9 years n=93 Participants	62.1 years n=4 Participants	62.0 years n=27 Participants	62.12 years n=483 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	3 Participants n=4 Participants	18 Participants n=27 Participants	27 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=93 Participants	3 Participants n=4 Participants	17 Participants n=27 Participants	25 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	3 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	5 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) White	5 Participants n=93 Participants	2 Participants n=4 Participants	10 Participants n=27 Participants	17 Participants n=483 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants

PRIMARY outcome

Timeframe: First cycle (28 days) of treatment

The number of dose limiting toxicities (DLTs) at each dose level will be reported. All toxicities will be reported by type and grade using NCI CTCAE version 4.03.

Outcome measures

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=6 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=18 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Safety and Tolerability of Fostamatinib	0 Dose Limiting Toxicities (DLTs)	0 Dose Limiting Toxicities (DLTs)	1 Dose Limiting Toxicities (DLTs)

PRIMARY outcome

Timeframe: 28 days

Population: Participants included in the dose-escalation are reported

The MTD will be determined as the dose level with the highest probability of having a risk of DLT in the acceptable region based on the mTPI dose-escalation design. Measured at 28 days (DLT period).

Outcome measures

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=12 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Maximum Tolerated Dose (MTD) of Fostamatinib	200 milligrams	—	—

SECONDARY outcome

Timeframe: 5 years

Number of participants within each objective response as seen on imaging/RECIST 1.1. Per response evaluation criteria in solid tumors criteria (RECIST v1.1) for target lesions: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; 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

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=6 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=18 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Objective Response Rate in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel Partial Response (PR)	1 Participants	0 Participants	7 Participants
Objective Response Rate in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel Stable Disease (SD)	0 Participants	1 Participants	5 Participants
Objective Response Rate in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel Progressive Disease (PD)	1 Participants	2 Participants	4 Participants
Objective Response Rate in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel Non-Evaluable (NE)	4 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 5 years

Progression-free survival (PFS) will be described by the method of Kaplan and Meier. Median PFS in months will be estimated along with its 95% confidence interval. Per response evaluation criteria in solid tumors (RECIST v1.1), Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=6 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=18 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Progression-free Survival in the Study Population Treated With the Combination of Fostamatinib and Paclitaxel	1.445 Months Interval 0.92 to Value is reported as NA because its estimate (from Greenwood's Formula and asymptotic normal distribution assumption) is larger than 1 (outside the range between 0 and 1).	1.81 Months Interval 1.22 to Value is reported as NA because its estimate (from Greenwood's Formula and asymptotic normal distribution assumption) is larger than 1 (outside the range between 0 and 1).	4.305 Months Interval 2.69 to 6.37

SECONDARY outcome

Timeframe: First cycle (28 days) of treatment

Population: 1 patient at the 100 mg dose and 1 patient at the 200 mg did not have all PKs drawn and were not included in the PK analysis

Tmax (hours) was used to summarize pharmacokinetic marker profile for fostamatinib. Tmax (hours): Time to reach maximum plasma concentration of R406, the active meta

Outcome measures

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=5 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=17 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Pharmacokinetic (PK) Profile of Fostamatinib When Combined With Weekly Paclitaxel - Tmax	1.96 hours Standard Deviation 2.26	1.69 hours Standard Deviation 1.13	1.9 hours Standard Deviation 1.10

SECONDARY outcome

Timeframe: First cycle (28 days) of treatment

Population: 1 patient at the 100 mg dose and 1 patient at the 200 mg did not have all PKs drawn and were not included in the PK analysis

Cmax (ng/mL) was used to summarize pharmacokinetic marker profile for fostamatinib. Cmax (ng/mL): Maximum plasma concentration of R406.

Outcome measures

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=5 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=17 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Pharmacokinetic (PK) Profile of Fostamatinib When Combined With Weekly Paclitaxel - Cmax	803.4 ng/ML Standard Deviation 452.0	1309.3 ng/ML Standard Deviation 599.7	1187.2 ng/ML Standard Deviation 784.0

SECONDARY outcome

Timeframe: First cycle (28 days) of treatment

Population: 1 patient at the 100 mg dose and 1 patient at the 200 mg did not have all PKs drawn and were not included in the PK analysis

AUC0-6h (ng\*h/mL) was used to summarize pharmacokinetic marker profile for fostamatinib. AUC0-6h (ng\*h/mL): Area under the concentration-time curve for R406 up to 6 hours post-dosing.

Outcome measures

Outcome measures
Measure	Fostamatinib 100 mg Bid and Paclitaxel n=5 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=17 Participants Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Pharmacokinetic (PK) Profile of Fostamatinib When Combined With Weekly Paclitaxel - Area Under the Curve (AUC) 0-6hours	2265.7 ng*h/mL Standard Deviation 1328.7	4067.3 ng*h/mL Standard Deviation 1177.8	3958.8 ng*h/mL Standard Deviation 2104.1

Adverse Events

Fostamatinib 100 mg Bid and Paclitaxel

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Fostamatinib 150 mg Bid and Paclitaxel

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fostamatinib 200 mg Bid and Paclitaxel

Serious events: 7 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Stephanie Gaillard, MD PhD

SKCCC at Johns Hopkins

Phone: 410-955-3774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Fostamatinib 100 mg Bid and Paclitaxel n=6 participants at risk Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 100mg twice daily throughout each 28-day cycle. Fostamatinib 100 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 100 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 150 mg Bid and Paclitaxel n=3 participants at risk Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 150 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 150 mg bid) Drug: Paclitaxel (60-80 mg/m2)	Fostamatinib 200 mg Bid and Paclitaxel n=18 participants at risk Participants will receive paclitaxel on Days 1, 8 and 15 of each cycle and fostamatinib at a fixed oral dose of 150mg twice daily throughout each 28-day cycle. Fostamatinib 200 mg bid and Paclitaxel: Drug: Fostamatinib (oral; 200 mg bid) Drug: Paclitaxel (60-80 mg/m2)
Infections and infestations Abdominal infection	16.7% 1/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonitis	16.7% 1/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Investigations Blood bilirubin increased	16.7% 1/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Infections and infestations Catheter related infection	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Vascular disorders Thromboembolic event	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	11.1% 2/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Nervous system disorders Headache	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Gastrointestinal disorders Ascites	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.
Infections and infestations Soft tissue infection	0.00% 0/6 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	0.00% 0/3 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.	5.6% 1/18 • AEs were collected from the time of first dose of study drug to 30 days after the last dose, up to 55 weeks.