Trial Outcomes & Findings for E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma (NCT NCT01401530)

Last Updated: 2018-11-23

Results Overview

The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)

Results posted on

2018-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: 6 ug/kg/Day Denileukin Diftitox Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Overall Study STARTED	3	7	3
Overall Study COMPLETED	0	1	0
Overall Study NOT COMPLETED	3	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: 6 ug/kg/Day Denileukin Diftitox Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Overall Study Disease Progression	1	2	1
Overall Study Adverse Event	1	1	1
Overall Study Participant Choice	1	2	1
Overall Study Physician Decision	0	1	0

Baseline Characteristics

E7777 for the Treatment of Patients With Peripheral T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: 6 ug/kg/Day Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=7 Participants Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=3 Participants Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Total n=13 Participants Total of all reporting groups
Age, Continuous	69.7 Years STANDARD_DEVIATION 5.51 • n=5 Participants	49.9 Years STANDARD_DEVIATION 17.74 • n=7 Participants	66.3 Years STANDARD_DEVIATION 4.16 • n=5 Participants	58.2 Years STANDARD_DEVIATION 15.98 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants

PRIMARY outcome

Timeframe: For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)

Population: DLT evaluation analysis set included all participants after excluding, from the Safety Analysis Set, participants who were non-evaluable for DLT.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=12 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Maximum Tolerated Dose (MTD) and Recommended Dose (RD)	9 ug/kg/day	—	—

SECONDARY outcome

Timeframe: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months

Population: Safety Analysis Set (SAS) included all participants who received at least one dose of the study drug with at least one evaluable, post-baseline safety datum.

Safety assessments consisted of monitoring and recording all AEs and SAEs; regular monitoring of hematology, blood coagulation, blood chemistry, and urinalysis values; periodic measurement of vital signs, body weight, 12-lead electrocardiograms (ECGs), Eastern Cooperative Oncology Group performance status, physical examination findings, and ophthalmological examination findings. TEAEs were defined as an AE that had an onset date, or worsening in severity from baseline (pre-treatment), on or after the first dose of study drug up to the last assessment. Treatment-related TEAEs included TEAEs that were considered by the investigator to be possibly or probably related to study drug. SAEs were defined as any untoward medical occurrence which results in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or caused a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=7 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=3 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox TEAEs	3 Participants	7 Participants	3 Participants
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox Treatment-related TEAEs	3 Participants	7 Participants	3 Participants
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox Treatment-emergent SAEs	1 Participants	3 Participants	1 Participants
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability of Denileukin Diftitox Death	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set included all participants in whom at least one PK parameter could be calculated.

Cmax was defined as the maximum observed concentration of denileukin diftitox following administration of study treatment on Cycle 1 Day 1 and was obtained directly from the measured serum concentration-time curves. Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a lower limit of quantitation (LLOQ) of 30 nanograms per milliliter (ng/mL). Serum pharmacokinetic (PK) data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Cmax, which was then summarized as the median and full range for all participants and expressed as ng/mL.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=5 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=2 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Maximum Serum Concentration (Cmax) of Denileukin Diftitox	129 ng/mL Interval 101.0 to 130.0	149 ng/mL Interval 135.0 to 245.0	181 ng/mL Interval 158.0 to 204.0

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Tmax, which was then summarized as the median and full range for all participants and expressed in minutes.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=5 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=2 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Time to Cmax (Tmax) of Denileukin Diftitox in Serum	64.000 Minutes Interval 64.0 to 86.0	64.000 Minutes Interval 60.0 to 98.0	74.500 Minutes Interval 64.0 to 85.0

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-t), which was then summarized as the median and full range for all participants and expressed as nanograms\*minutes per milliliter (ng\*min/mL).

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=5 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=2 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC(0-t))	10300 ng*min/mL Interval 9860.0 to 12700.0	16900 ng*min/mL Interval 9980.0 to 21700.0	18600 ng*min/mL Interval 14000.0 to 23200.0

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of AUC(0-inf), which was then summarized as the median and full range for all participants and expressed as ng\*min/mL.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=4 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=1 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf))	16800 ng*min/mL Interval 16300.0 to 18900.0	25200 ng*min/mL Interval 13300.0 to 28600.0	35600 ng*min/mL Interval 35600.0 to 35600.0

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of λz, which was then summarized as the median and full range for all participants and expressed in 1/minutes.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=4 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=1 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Terminal Phase Rate Constant (λz)	0.00746 1/minutes Interval 0.00647 to 0.00895	0.0103 1/minutes Interval 0.00656 to 0.0115	0.00793 1/minutes Interval 0.00793 to 0.00793

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of t1/2, which was then summarized as the median and full range for all participants and expressed in minutes.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=4 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=1 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Terminal Elimination Phase Half-life (t1/2)	92.9 Minutes Interval 77.5 to 107.0	67.8 Minutes Interval 60.2 to 106.0	87.4 Minutes Interval 87.4 to 87.4

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vz, which was then summarized as the median and full range for all participants and expressed as milliliters per kilogram (mL/kg).

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=4 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=1 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Volume of Distribution at Terminal Phase (Vz)	54.2 mL/kg Interval 46.8 to 57.3	45.2 mL/kg Interval 29.7 to 58.9	49.5 mL/kg Interval 49.5 to 49.5

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. Serum PK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of Vss, which was then summarized as the median and full range for all participants and expressed as mL/kg.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=4 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=1 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Volume of Distribution at Steady State (Vss)	59.8 mL/kg Interval 54.7 to 60.7	48.4 mL/kg Interval 32.3 to 62.3	54.1 mL/kg Interval 54.1 to 54.1

SECONDARY outcome

Timeframe: Cycle 1 (Day 1)

Population: PK analysis set

Blood samples were collected before and 30 minutes after the start of infusion and immediately (0 minutes), 30, 60, 90, and 120 minutes after the end of infusion of denileukin diftitox. The samples were analyzed for the amount of denileukin diftitox in the serum using a validated ligand-binding assay with a LLOQ of 30 ng/mL. SerumPK data were analyzed using a non-compartmental analysis approach to obtain individual participant estimates of CL, which was then summarized as the median and full range for all participants and expressed as milliliters/minutes/kilograms (mL/min/kg).

Outcome measures

Outcome measures
Measure	Denileukin Diftitox n=3 Participants Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=4 Participants Denileukin diftitox (9 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=1 Participants Denileukin diftitox (12 ug/kg/day) was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Total Clearance (CL)	0.404 mL/min/kg Interval 0.371 to 0.418	0.361 mL/min/kg Interval 0.321 to 0.679	0.393 mL/min/kg Interval 0.393 to 0.393

SECONDARY outcome

Timeframe: For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)

Population: This endpoint was combined with primary outcome measure, MTD

This endpoint was combined with primary outcome measure, MTD

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: 6 ug/kg/Day Denileukin Diftitox

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Cohort 2: 9 ug/kg/Day Denileukin Diftitox

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 3: 12 ug/kg/Day Denileukin Diftitox

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: 6 ug/kg/Day Denileukin Diftitox n=3 participants at risk Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 2: 9 ug/kg/Day Denileukin Diftitox n=7 participants at risk Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).	Cohort 3: 12 ug/kg/Day Denileukin Diftitox n=3 participants at risk Denileukin diftitox was IV-infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	14.3% 1/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Psychiatric disorders Delirium	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	14.3% 1/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	14.3% 1/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Investigations Aspartate Aminotransferase increased	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	14.3% 1/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	14.3% 1/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
General disorders Fatigue	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	14.3% 1/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Infections and infestations Infected skin ulcer	33.3% 1/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	33.3% 1/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.
Hepatobiliary disorders Hepatic Failure	0.00% 0/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	0.00% 0/7 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.	33.3% 1/3 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 4 years 2 months Treatment-emergent adverse events and serious adverse events were reported. Adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was used and included all participants who received at least one dose of study drug with at least one evaluable, post-baseline safety datum.

Other adverse events

Additional Information

Eisai Medical Services Inc.

Eisai Inc.

Phone: 1-888-422-4743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER