Trial Outcomes & Findings for ARRx in Combination With Enzalutamide in Metastatic Castration Resistant Prostate Cancer (NCT NCT03300505)
NCT ID: NCT03300505
Last Updated: 2025-05-13
Results Overview
DLTs will be counted based on the number of subjects with DLT at a given dose level. No single subject can trigger more than one DLT event. DLT is defined as any Grade 3 or higher toxicity as defined by CTCAE v5.0. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
Up to day 21 of treatment
Results posted on
2025-05-13
Participant Flow
Participant milestones
| Measure |
Dose Level 1: 600 mg IONIS
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV)
Enzalutamide: Given by mouth (PO)
Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Dose Level 2: 750 mg IONIS
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV)
Enzalutamide: Given by mouth (PO)
Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Dose Level 3: 900 mg IONIS
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV)
Enzalutamide: Given by mouth (PO)
Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
5
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
3
|
Reasons for withdrawal
| Measure |
Dose Level 1: 600 mg IONIS
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV)
Enzalutamide: Given by mouth (PO)
Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Dose Level 2: 750 mg IONIS
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV)
Enzalutamide: Given by mouth (PO)
Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Dose Level 3: 900 mg IONIS
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV)
Enzalutamide: Given by mouth (PO)
Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Sponsor Termination
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
Baseline Characteristics
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=1 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS
Dose Level 2: 750 mg IONIS
Dose Level 3: 900 mg IONIS
|
Dose Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Dose Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
1 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
1 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
2 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Age, Categorical
>=65 years
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
4 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
2 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
6 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Sex: Female, Male
Female
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Sex: Female, Male
Male
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
5 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
3 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
8 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
5 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
3 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
8 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
Asian
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
1 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
1 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
2 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
White
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
4 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
2 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
6 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0 Participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Region of Enrollment
United States
|
—
|
5 participants
n=5 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
3 participants
n=3 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
8 participants
n=8 Participants • Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
PRIMARY outcome
Timeframe: Up to day 21 of treatmentPopulation: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
DLTs will be counted based on the number of subjects with DLT at a given dose level. No single subject can trigger more than one DLT event. DLT is defined as any Grade 3 or higher toxicity as defined by CTCAE v5.0. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded from this definition.
Outcome measures
| Measure |
Level 1
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Number of Subjects With Dose-limiting Toxicity (DLT) During the First Cycle of ARRx (in Combination With Enzalutamide)
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3.5 yearsPopulation: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
Number of subjects with at least 50% decline in PSA from Baseline
Outcome measures
| Measure |
Level 1
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Best PSA Response
|
—
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
Using PCWG3 criteria. Number of patient with a reduction in PSA of at least 30% from baseline
Outcome measures
| Measure |
Level 1
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Percentage of Patients With a Reduction in PSA of at Least 30% From Baseline
|
—
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
One year KM estimate. Patients alive or lost to follow-up at the time of analysis will be censored at their last date of follow-up.
Outcome measures
| Measure |
Level 1
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Overall Survival at One Year
|
—
|
67 percentage of participants
Interval 5.0 to 95.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
Number of participants that experienced dose delays while on study treatment
Outcome measures
| Measure |
Level 1
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Intrapatient Dose Delays
|
—
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 3.5 yearsPopulation: Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
Number of participants that experienced dose reductions while on study treatment
Outcome measures
| Measure |
Level 1
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 Participants
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Intrapatient Dose Reductions
|
—
|
1 Participants
|
1 Participants
|
Adverse Events
Level 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Level 2
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Level 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Level 1
n=1 participants at risk
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 participants at risk
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 participants at risk
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Sepsis
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Fever
|
0.00%
0/1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
Other adverse events
| Measure |
Level 1
n=1 participants at risk
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 2
n=5 participants at risk
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
Level 3
n=3 participants at risk
Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity.
ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
40.0%
2/5 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
100.0%
3/3 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Psychiatric disorders
Anxiety
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
40.0%
2/5 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
100.0%
3/3 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Investigations
Blood lactate dehydrogenase increased
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Injury, poisoning and procedural complications
Bruising
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Chills
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
40.0%
2/5 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
66.7%
2/3 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Nervous system disorders
Dizziness
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Edema limbs
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Fatigue
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
60.0%
3/5 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
66.7%
2/3 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Fever
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Flu like symptoms
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Nervous system disorders
Headache
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
40.0%
2/5 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Vascular disorders
Hot flashes
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Metabolism and nutrition disorders
Hypokalemia
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Psychiatric disorders
Insomnia
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
20.0%
1/5 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
General disorders
Pain
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
100.0%
3/3 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Nervous system disorders
Paresthesia
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Vascular disorders
Thromboembolic event
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Renal and urinary disorders
Urinary retention
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Gastrointestinal disorders
Vomiting
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
66.7%
2/3 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
|
Investigations
Weight loss
|
—
0/0 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
0.00%
0/5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
33.3%
1/3 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
|
Additional Information
University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin
University of Michigan Rogel Cancer Center
Phone: 734-936-9499
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place