Trial Outcomes & Findings for Study of ADI-PEG 20 in Patients With Advanced Melanoma (NCT NCT00520299)

NCT ID: NCT00520299

Last Updated: 2022-10-25

Results Overview

Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Every 1 to 2 weeks for up to 12 months

Results posted on

2022-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Overall Study STARTED	6	6	19
Overall Study COMPLETED	6	3	13
Overall Study NOT COMPLETED	0	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Overall Study Withdrawal by Subject	0	0	2
Overall Study Progressive disease	0	3	4

Baseline Characteristics

Study of ADI-PEG 20 in Patients With Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20	Total n=31 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 18.2 • n=5 Participants	61.2 years STANDARD_DEVIATION 14.7 • n=7 Participants	67.2 years STANDARD_DEVIATION 11.2 • n=5 Participants	64.9 years STANDARD_DEVIATION 13.2 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants	29 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	18 Participants n=5 Participants	30 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
BMI	22.0 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants	24.7 kg/m^2 STANDARD_DEVIATION 1.8 • n=7 Participants	26.9 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants	25.5 kg/m^2 STANDARD_DEVIATION 4.5 • n=4 Participants
ASS Assay Result Negative	4 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants	24 participants n=4 Participants
ASS Assay Result ≤5% positive	2 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	5 participants n=4 Participants
ASS Assay Result Not done	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: Every 1 to 2 weeks for up to 12 months

Population: Safety Analysis Set (all subjects who received at least 1 dose of ADI-PEG 20)

Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Assessment of Safety and Tolerability of ADI-PEG 20 Grade 4 TEAE	0 participants	1 participants	1 participants
Assessment of Safety and Tolerability of ADI-PEG 20 Any TEAE	6 participants	6 participants	19 participants
Assessment of Safety and Tolerability of ADI-PEG 20 Grade 3 TEAE	1 participants	2 participants	4 participants
Assessment of Safety and Tolerability of ADI-PEG 20 Grade 5 TEAE (Death)	0 participants	0 participants	1 participants
Assessment of Safety and Tolerability of ADI-PEG 20 Treatment-related TEAE	5 participants	5 participants	17 participants
Assessment of Safety and Tolerability of ADI-PEG 20 SAE	4 participants	1 participants	6 participants
Assessment of Safety and Tolerability of ADI-PEG 20 TEAE leading to withdrawal	0 participants	1 participants	3 participants

PRIMARY outcome

Timeframe: Every 8 to 9 weeks for up to 12 months

Population: Includes all subjects who completed the study as planned or had tumor progression during the study

Clinical tumor responses were evaluated using disease imaging (CT preferred) performed at baseline and at the end of every cycle. Responses were categorized according to RECIST. Per RECIST for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=17 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Best Overall Clinical Tumor Response Complete/partial response	0 participants	0 participants	0 participants
Best Overall Clinical Tumor Response Stable disease	3 participants	2 participants	4 participants
Best Overall Clinical Tumor Response Progressive disease	3 participants	4 participants	13 participants

SECONDARY outcome

Timeframe: Every 8 to 9 weeks for up to 12 months

Population: Includes all subjects who completed the study as planned or had tumor progression during the study

Metabolic tumor responses were evaluated using fluorodeoxyglucose (FDG) positron emission tomography (PET) at baseline, on day 4, and at the end of every cycle.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=17 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Metabolic Tumor Response Cycle 1 Day 4: Partial metabolic response	1 participants	0 participants	6 participants
Metabolic Tumor Response Cycle 1 Day 4: Stable metabolic disease	2 participants	3 participants	6 participants
Metabolic Tumor Response Cycle 1 Day 4: Progressive metabolic disease	3 participants	2 participants	4 participants
Metabolic Tumor Response Cycle 1 Day 4: Missing	0 participants	1 participants	1 participants
Metabolic Tumor Response Cycle 1 Day 50: Partial metabolic response	0 participants	1 participants	0 participants
Metabolic Tumor Response Cycle 1 Day 50: Stable metabolic disease	4 participants	3 participants	5 participants
Metabolic Tumor Response Cycle 1 Day 50: Progressive metabolic disease	2 participants	1 participants	9 participants
Metabolic Tumor Response Cycle 1 Day 50: Missing	0 participants	1 participants	3 participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Includes all subjects who had at least 1 post-baseline blood sample with associated pharmacokinetic analysis. Means are presented for time points at which \>1 subject in any arm contributed data.

Blood samples were collected on day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for ADI-PEG 20 plasma concentrations.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=5 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 0	3.3 nM Standard Deviation 2.9	4.4 nM Standard Deviation 5.2	1.9 nM Standard Deviation 1.7
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 4	35.5 nM Standard Deviation 16.0	59.8 nM Standard Deviation 35.7	57.2 nM Standard Deviation 39.9
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 8	33.2 nM Standard Deviation 17.2	46.3 nM Standard Deviation 33.8	60.9 nM Standard Deviation 35.5
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 15	37.7 nM Standard Deviation 27.2	49.8 nM Standard Deviation 59.4	54.0 nM Standard Deviation 36.4
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 22	24.1 nM Standard Deviation 16.9	61.2 nM Standard Deviation 63.8	47.5 nM Standard Deviation 40.2
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 29	16.8 nM Standard Deviation 11.1	54.0 nM Standard Deviation 58.2	40.9 nM Standard Deviation 42.3
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 36	11.2 nM Standard Deviation 11.7	50.0 nM Standard Deviation 65.3	27.1 nM Standard Deviation 42.3
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 43	12.0 nM Standard Deviation 10.7	34.9 nM Standard Deviation 47.2	11.9 nM Standard Deviation 20.2
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 50	11.0 nM Standard Deviation 14.9	19.0 nM Standard Deviation 26.2	13.2 nM Standard Deviation 25.7
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 57	8.4 nM Standard Deviation 10.5	9.3 nM Standard Deviation 10.3	10.0 nM Standard Deviation 15.6
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 64	8.0 nM Standard Deviation 9.1	14.7 nM Standard Deviation 17.3	10.0 nM Standard Deviation 16.2
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 71	2.6 nM Standard Deviation 1.3	1.5 nM Standard Deviation 0.7	3.8 nM Standard Deviation 2.9
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 78	2.8 nM Standard Deviation 1.1	0.6 nM Standard Deviation 0.8	2.6 nM Standard Deviation 1.2
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 85	0.5 nM Standard Deviation 0.7	0.2 nM Standard Deviation 0.0	2.2 nM Standard Deviation 1.9
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 92	0.9 nM Standard Deviation 0.8	0.6 nM Standard Deviation 0.4	2.6 nM Standard Deviation 2.9
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 99	0.9 nM Standard Deviation 1.1	2.2 nM Standard Deviation NA Only 1 participant contributed data at this time point.	2.4 nM Standard Deviation 1.7
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 106	1.0 nM Standard Deviation 1.7	3.1 nM Standard Deviation NA Only 1 participant contributed data at this time point.	0.9 nM Standard Deviation 0.8
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 113	0.9 nM Standard Deviation 0.1	2.0 nM Standard Deviation NA Only 1 participant contributed data at this time point.	1.6 nM Standard Deviation 1.8
Summary of ADI-PEG 20 Plasma Concentrations Over Time Day 120	2.1 nM Standard Deviation 0.7	3.0 nM Standard Deviation NA Only 1 participant contributed data at this time point.	4.0 nM Standard Deviation 2.4

SECONDARY outcome

Timeframe: Up to 9 months

Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma arginine levels.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=5 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Summary of Plasma Arginine Levels Over Time Day 0	55 uM Standard Deviation 17	62 uM Standard Deviation 22	49 uM Standard Deviation 11
Summary of Plasma Arginine Levels Over Time Day 4	2 uM Standard Deviation 0	9 uM Standard Deviation 20	4 uM Standard Deviation 11
Summary of Plasma Arginine Levels Over Time Day 8	2 uM Standard Deviation 0	12 uM Standard Deviation 18	3 uM Standard Deviation 7
Summary of Plasma Arginine Levels Over Time Day 15	4 uM Standard Deviation 6	29 uM Standard Deviation 22	7 uM Standard Deviation 16
Summary of Plasma Arginine Levels Over Time Day 22	9 uM Standard Deviation 11	22 uM Standard Deviation 23	21 uM Standard Deviation 33
Summary of Plasma Arginine Levels Over Time Day 29	14 uM Standard Deviation 24	19 uM Standard Deviation 24	23 uM Standard Deviation 32
Summary of Plasma Arginine Levels Over Time Day 36	20 uM Standard Deviation 28	29 uM Standard Deviation 26	31 uM Standard Deviation 34
Summary of Plasma Arginine Levels Over Time Day 43	23 uM Standard Deviation 34	35 uM Standard Deviation 31	48 uM Standard Deviation 44
Summary of Plasma Arginine Levels Over Time Day 50	58 uM Standard Deviation 46	24 uM Standard Deviation 21	44 uM Standard Deviation 37
Summary of Plasma Arginine Levels Over Time Day 57	38 uM Standard Deviation 30	27 uM Standard Deviation 22	40 uM Standard Deviation 31
Summary of Plasma Arginine Levels Over Time Day 64	30 uM Standard Deviation 29	30 uM Standard Deviation 26	42 uM Standard Deviation 35
Summary of Plasma Arginine Levels Over Time Day 71	68 uM Standard Deviation 33	63 uM Standard Deviation 13	50 uM Standard Deviation 34
Summary of Plasma Arginine Levels Over Time Day 78	78 uM Standard Deviation 39	105 uM Standard Deviation 2	60 uM Standard Deviation 26
Summary of Plasma Arginine Levels Over Time Day 85	75 uM Standard Deviation 38	64 uM Standard Deviation 28	74 uM Standard Deviation 24
Summary of Plasma Arginine Levels Over Time Day 92	98 uM Standard Deviation 42	95 uM Standard Deviation 6	71 uM Standard Deviation 23
Summary of Plasma Arginine Levels Over Time Day 99	67 uM Standard Deviation 11	89 uM Standard Deviation NA Only 1 participant contributed data at this time point.	52 uM Standard Deviation 16
Summary of Plasma Arginine Levels Over Time Day 106	52 uM Standard Deviation 34	43 uM Standard Deviation NA Only 1 participant contributed data at this time point.	77 uM Standard Deviation 28
Summary of Plasma Arginine Levels Over Time Day 113	59 uM Standard Deviation 15	53 uM Standard Deviation NA Only 1 participant contributed data at this time point.	59 uM Standard Deviation 7
Summary of Plasma Arginine Levels Over Time Day 120	64 uM Standard Deviation 34	59 uM Standard Deviation NA Only 1 participant contributed data at this time point.	60 uM Standard Deviation 16

SECONDARY outcome

Timeframe: Up to 9 months

Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for plasma citrulline levels.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=5 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Summary of Plasma Citrulline Levels Over Time Day 120	37 uM Standard Deviation 14	47 uM Standard Deviation NA Only 1 participant contributed data at this time point.	22 uM Standard Deviation 8
Summary of Plasma Citrulline Levels Over Time Day 0	38 uM Standard Deviation 17	29 uM Standard Deviation 8	23 uM Standard Deviation 14
Summary of Plasma Citrulline Levels Over Time Day 4	195 uM Standard Deviation 89	158 uM Standard Deviation 84	225 uM Standard Deviation 106
Summary of Plasma Citrulline Levels Over Time Day 8	152 uM Standard Deviation 40	121 uM Standard Deviation 51	280 uM Standard Deviation 125
Summary of Plasma Citrulline Levels Over Time Day 15	127 uM Standard Deviation 71	125 uM Standard Deviation 122	280 uM Standard Deviation 150
Summary of Plasma Citrulline Levels Over Time Day 22	141 uM Standard Deviation 102	174 uM Standard Deviation 165	245 uM Standard Deviation 175
Summary of Plasma Citrulline Levels Over Time Day 29	99 uM Standard Deviation 59	126 uM Standard Deviation 126	169 uM Standard Deviation 148
Summary of Plasma Citrulline Levels Over Time Day 36	116 uM Standard Deviation 75	104 uM Standard Deviation 115	139 uM Standard Deviation 149
Summary of Plasma Citrulline Levels Over Time Day 43	106 uM Standard Deviation 81	135 uM Standard Deviation 149	71 uM Standard Deviation 72
Summary of Plasma Citrulline Levels Over Time Day 50	58 uM Standard Deviation 31	77 uM Standard Deviation 88	66 uM Standard Deviation 76
Summary of Plasma Citrulline Levels Over Time Day 57	71 uM Standard Deviation 51	47 uM Standard Deviation 29	64 uM Standard Deviation 76
Summary of Plasma Citrulline Levels Over Time Day 64	76 uM Standard Deviation 80	108 uM Standard Deviation 133	60 uM Standard Deviation 54
Summary of Plasma Citrulline Levels Over Time Day 71	35 uM Standard Deviation 9	19 uM Standard Deviation 9	45 uM Standard Deviation 34
Summary of Plasma Citrulline Levels Over Time Day 78	40 uM Standard Deviation 12	44 uM Standard Deviation 29	30 uM Standard Deviation 19
Summary of Plasma Citrulline Levels Over Time Day 85	50 uM Standard Deviation 30	23 uM Standard Deviation 6	32 uM Standard Deviation 11
Summary of Plasma Citrulline Levels Over Time Day 92	44 uM Standard Deviation 21	27 uM Standard Deviation 2	29 uM Standard Deviation 18
Summary of Plasma Citrulline Levels Over Time Day 99	33 uM Standard Deviation 13	31 uM Standard Deviation NA Only 1 participant contributed data at this time point.	23 uM Standard Deviation 12
Summary of Plasma Citrulline Levels Over Time Day 106	33 uM Standard Deviation 21	33 uM Standard Deviation NA Only 1 participant contributed data at this time point.	29 uM Standard Deviation 10
Summary of Plasma Citrulline Levels Over Time Day 113	35 uM Standard Deviation 12	22 uM Standard Deviation NA Only 1 participant contributed data at this time point.	23 uM Standard Deviation 10

SECONDARY outcome

Timeframe: Up to 12 months

Blood samples were collected at baseline, day 1 (pre-injection), day 4, day 8, and every 7 days thereafter for detection of anti-ADI antibodies.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=5 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Summary of ADI-PEG 20 Immunogenicity Over Time Day 0	0.2 log 10 U/mL Standard Deviation 0.4	0.2 log 10 U/mL Standard Deviation 0.5	0.1 log 10 U/mL Standard Deviation 0.3
Summary of ADI-PEG 20 Immunogenicity Over Time Day 4	0.2 log 10 U/mL Standard Deviation 0.4	0.0 log 10 U/mL Standard Deviation 0.0	0.4 log 10 U/mL Standard Deviation 0.5
Summary of ADI-PEG 20 Immunogenicity Over Time Day 8	0.2 log 10 U/mL Standard Deviation 0.4	0.4 log 10 U/mL Standard Deviation 0.5	0.4 log 10 U/mL Standard Deviation 0.5
Summary of ADI-PEG 20 Immunogenicity Over Time Day 15	0.5 log 10 U/mL Standard Deviation 0.5	0.6 log 10 U/mL Standard Deviation 0.5	0.8 log 10 U/mL Standard Deviation 0.4
Summary of ADI-PEG 20 Immunogenicity Over Time Day 22	0.5 log 10 U/mL Standard Deviation 0.5	1.0 log 10 U/mL Standard Deviation 0.6	0.7 log 10 U/mL Standard Deviation 0.5
Summary of ADI-PEG 20 Immunogenicity Over Time Day 29	0.8 log 10 U/mL Standard Deviation 0.4	1.4 log 10 U/mL Standard Deviation 0.5	1.3 log 10 U/mL Standard Deviation 0.9
Summary of ADI-PEG 20 Immunogenicity Over Time Day 36	0.8 log 10 U/mL Standard Deviation 0.8	1.8 log 10 U/mL Standard Deviation 0.4	1.9 log 10 U/mL Standard Deviation 1.1
Summary of ADI-PEG 20 Immunogenicity Over Time Day 43	1.2 log 10 U/mL Standard Deviation 1.2	1.8 log 10 U/mL Standard Deviation 0.4	2.4 log 10 U/mL Standard Deviation 1.2
Summary of ADI-PEG 20 Immunogenicity Over Time Day 50	1.5 log 10 U/mL Standard Deviation 1.2	2.2 log 10 U/mL Standard Deviation 0.4	2.9 log 10 U/mL Standard Deviation 1.5
Summary of ADI-PEG 20 Immunogenicity Over Time Day 57	1.5 log 10 U/mL Standard Deviation 0.8	2.4 log 10 U/mL Standard Deviation 0.5	3.0 log 10 U/mL Standard Deviation 1.2
Summary of ADI-PEG 20 Immunogenicity Over Time Day 64	2.0 log 10 U/mL Standard Deviation 1.0	2.0 log 10 U/mL Standard Deviation 0.0	3.0 log 10 U/mL Standard Deviation 1.3
Summary of ADI-PEG 20 Immunogenicity Over Time Day 71	2.3 log 10 U/mL Standard Deviation 0.6	2.5 log 10 U/mL Standard Deviation 0.7	3.5 log 10 U/mL Standard Deviation 0.6
Summary of ADI-PEG 20 Immunogenicity Over Time Day 78	2.7 log 10 U/mL Standard Deviation 0.6	2.5 log 10 U/mL Standard Deviation 0.7	4.0 log 10 U/mL Standard Deviation 0.8
Summary of ADI-PEG 20 Immunogenicity Over Time Day 85	2.7 log 10 U/mL Standard Deviation 0.6	2.0 log 10 U/mL Standard Deviation 0.0	4.0 log 10 U/mL Standard Deviation 0.8
Summary of ADI-PEG 20 Immunogenicity Over Time Day 92	3.0 log 10 U/mL Standard Deviation 0.0	3.0 log 10 U/mL Standard Deviation 0.0	4.0 log 10 U/mL Standard Deviation 0.8
Summary of ADI-PEG 20 Immunogenicity Over Time Day 99	3.0 log 10 U/mL Standard Deviation 1.0	3.0 log 10 U/mL Standard Deviation NA Only 1 participant contributed data at this time point.	3.8 log 10 U/mL Standard Deviation 1.3
Summary of ADI-PEG 20 Immunogenicity Over Time Day 106	3.0 log 10 U/mL Standard Deviation 1.0	3.0 log 10 U/mL Standard Deviation NA Only 1 participant contributed data at this time point.	4.0 log 10 U/mL Standard Deviation 0.8
Summary of ADI-PEG 20 Immunogenicity Over Time Day 113	3.0 log 10 U/mL Standard Deviation 0.0	2.0 log 10 U/mL Standard Deviation NA Only 1 participant contributed data at this time point.	4.0 log 10 U/mL Standard Deviation 1.4
Summary of ADI-PEG 20 Immunogenicity Over Time Day 120	3.0 log 10 U/mL Standard Deviation 0.0	4.0 log 10 U/mL Standard Deviation NA Only 1 participant contributed data at this time point.	4.5 log 10 U/mL Standard Deviation 1.3

SECONDARY outcome

Timeframe: Up to 12 months

Population: Includes all subjects who had an ASS antigen assay performed at Baseline

Expression of ASS was analyzed by immunohistochemistry in tumor samples (archived or biopsy) at baseline and compared with overall best clinical response per RECIST. ASS tumor expression is categorized as either negative or ≤ 5% positive tumor cells.

Outcome measures

Outcome measures
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=6 Participants Includes subjects enrolled to receive 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=17 Participants Includes subjects enrolled to receive 160 IU/m\^2/week of ADI-PEG 20
Correlation Between ASS Tumor Expression and Clinical Response ≤5% Positive ASS & Progressive Disease	2 participants	0 participants	3 participants
Correlation Between ASS Tumor Expression and Clinical Response Negative ASS & Stable Disease	1 participants	1 participants	0 participants
Correlation Between ASS Tumor Expression and Clinical Response Negative ASS & Progressive Disease	3 participants	5 participants	12 participants
Correlation Between ASS Tumor Expression and Clinical Response Negative ASS & Missing Response	0 participants	0 participants	2 participants

Adverse Events

Cohort 1: ADI-PEG 20 40 IU/m^2/Week

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2: ADI-PEG 20 80 IU/m^2/Week

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 3: ADI-PEG 20 160 IU/m^2/Week

Serious events: 6 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: ADI-PEG 20 40 IU/m^2/Week n=6 participants at risk Includes subjects who received 40 IU/m\^2/week of ADI-PEG 20	Cohort 2: ADI-PEG 20 80 IU/m^2/Week n=6 participants at risk Includes subjects who received 80 IU/m\^2/week of ADI-PEG 20	Cohort 3: ADI-PEG 20 160 IU/m^2/Week n=19 participants at risk Includes subjects who received 160 IU/m\^2/week of ADI-PEG 20
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 1/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	16.7% 1/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Nervous system disorders Headache	33.3% 2/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Gastrointestinal disorders Nausea	16.7% 1/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Gastrointestinal disorders Vomiting	16.7% 1/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Surgical and medical procedures Skin neoplasm excision	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	16.7% 1/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Nervous system disorders Convulsion	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Surgical and medical procedures Lymphadenectomy	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Nervous system disorders Cerebral haemorrhage	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade
Nervous system disorders Grand mal convulsion	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	0.00% 0/6 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade	5.3% 1/19 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). AE documentation included onset/resolution dates, severity using NCI CTCAE (v4.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per subject at the maximum reported grade

Other adverse events

Additional Information

Jonathan Skipper PhD

Ludwig Institute for Cancer Research

Phone: 12124501539

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60