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Trial Outcomes & Findings for A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT02711956)

NCT ID: NCT02711956

Last Updated: 2021-11-30

Results Overview

Determination of DLT was made during the first 28 days of treatment in the dose escalation phase. A DLT is defined as a clinically significant AE or laboratory abnormality that is considered possibly, probably, or definitely related to study drug. The MTD reflects the highest dose of ZEN003694 in combination with enzalutamide that did not cause a DLT in more than 1 of 6 patients. The RP2D is the recommended dose of ZEN003694 in combination with enzalutamide as determined in the dose confirmation phase of the study.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Cycle 1 (Day 1 thru Day 28)

Results posted on

2021-11-30

Participant Flow

The study was conducted at seven investigational sites in the United States between December 2016 and November 2019

75 participants were enrolled and treated in the study.

Participant milestones

Participant milestones
Measure
DE-A - 48 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 120 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 144 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 36 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 48 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-A 48 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-A 96 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
DC-B 48 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
DC-B 96 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
Overall Study
STARTED
2
2
3
5
4
3
4
4
4
3
1
9
17
6
8
Overall Study
COMPLETED
0
0
1
2
0
1
0
2
0
0
0
0
1
1
0
Overall Study
NOT COMPLETED
2
2
2
3
4
2
4
2
4
3
1
9
16
5
8

Reasons for withdrawal

Reasons for withdrawal
Measure
DE-A - 48 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 120 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 144 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 36 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 48 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-A 48 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-A 96 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
DC-B 48 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
DC-B 96 mg ZEN003694 + Enzalutamide
Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles
Overall Study
Adverse Event
0
0
0
1
2
0
0
1
1
1
1
0
0
0
2
Overall Study
Physician Decision
0
0
0
2
0
0
0
0
0
0
0
0
0
0
0
Overall Study
Withdrawal by Subject
0
0
0
0
0
0
1
0
0
0
0
1
6
0
1
Overall Study
Clinical progression
1
0
0
0
0
0
1
0
1
0
0
2
4
1
1
Overall Study
Radiographic progression
1
1
2
0
1
0
0
0
2
1
0
5
3
0
1
Overall Study
PSA progression with clinical progression
0
0
0
0
1
0
0
0
0
0
0
0
1
1
0
Overall Study
PSA progression with radiographic progression
0
1
0
0
0
2
2
1
0
1
0
1
2
3
3

Baseline Characteristics

BMI not available for one participant in DC-A 48 mg

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DE-A - 48 mg ZEN003694 + Enzalutamide
n=2 Participants
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 60 mg ZEN003694 + Enzalutamide
n=2 Participants
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 72 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 96 mg ZEN003694 + Enzalutamide
n=5 Participants
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 120 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-A - 144 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 36 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 48 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 60 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 72 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE-B - 96 mg ZEN003694 + Enzalutamide
n=1 Participants
Dose Escalation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-A - 48 mg ZEN003694 + Enzalutamide
n=9 Participants
Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-A - 96 mg ZEN003694 + Enzalutamide
n=17 Participants
Dose Confirmation - Cohort A - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-B - 48 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DC-B - 96 mg ZEN003694 + Enzalutamide
n=8 Participants
Dose Confirmation - Cohort B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Total
n=75 Participants
Total of all reporting groups
Age, Continuous
69.5 years
n=2 Participants
63 years
n=2 Participants
74 years
n=3 Participants
63 years
n=5 Participants
67.5 years
n=4 Participants
72 years
n=3 Participants
73.5 years
n=4 Participants
63.5 years
n=4 Participants
74.5 years
n=4 Participants
71 years
n=3 Participants
62 years
n=1 Participants
66 years
n=9 Participants
70 years
n=17 Participants
67 years
n=6 Participants
72 years
n=8 Participants
70 years
n=75 Participants
Sex: Female, Male
Female
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
0 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
0 Participants
n=75 Participants
Sex: Female, Male
Male
2 Participants
n=2 Participants
2 Participants
n=2 Participants
3 Participants
n=3 Participants
5 Participants
n=5 Participants
4 Participants
n=4 Participants
3 Participants
n=3 Participants
4 Participants
n=4 Participants
4 Participants
n=4 Participants
4 Participants
n=4 Participants
3 Participants
n=3 Participants
1 Participants
n=1 Participants
9 Participants
n=9 Participants
17 Participants
n=17 Participants
6 Participants
n=6 Participants
8 Participants
n=8 Participants
75 Participants
n=75 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
1 Participants
n=3 Participants
0 Participants
n=1 Participants
1 Participants
n=9 Participants
1 Participants
n=17 Participants
0 Participants
n=6 Participants
2 Participants
n=8 Participants
7 Participants
n=75 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=2 Participants
2 Participants
n=2 Participants
3 Participants
n=3 Participants
4 Participants
n=5 Participants
4 Participants
n=4 Participants
3 Participants
n=3 Participants
4 Participants
n=4 Participants
4 Participants
n=4 Participants
4 Participants
n=4 Participants
2 Participants
n=3 Participants
1 Participants
n=1 Participants
8 Participants
n=9 Participants
16 Participants
n=17 Participants
6 Participants
n=6 Participants
6 Participants
n=8 Participants
68 Participants
n=75 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
0 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
0 Participants
n=75 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
0 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
0 Participants
n=75 Participants
Race (NIH/OMB)
Asian
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
4 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
4 Participants
n=75 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
0 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
0 Participants
n=75 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
1 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
2 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
4 Participants
n=75 Participants
Race (NIH/OMB)
White
1 Participants
n=2 Participants
2 Participants
n=2 Participants
3 Participants
n=3 Participants
4 Participants
n=5 Participants
4 Participants
n=4 Participants
3 Participants
n=3 Participants
4 Participants
n=4 Participants
3 Participants
n=4 Participants
4 Participants
n=4 Participants
2 Participants
n=3 Participants
1 Participants
n=1 Participants
7 Participants
n=9 Participants
11 Participants
n=17 Participants
6 Participants
n=6 Participants
8 Participants
n=8 Participants
63 Participants
n=75 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=1 Participants
0 Participants
n=9 Participants
0 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
0 Participants
n=75 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=2 Participants
0 Participants
n=2 Participants
0 Participants
n=3 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=3 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
0 Participants
n=4 Participants
1 Participants
n=3 Participants
0 Participants
n=1 Participants
2 Participants
n=9 Participants
0 Participants
n=17 Participants
0 Participants
n=6 Participants
0 Participants
n=8 Participants
4 Participants
n=75 Participants
Mean Body Mass Index
25.26 kg/m^2
STANDARD_DEVIATION 1.854 • n=2 Participants • BMI not available for one participant in DC-A 48 mg
38.54 kg/m^2
STANDARD_DEVIATION 0.882 • n=2 Participants • BMI not available for one participant in DC-A 48 mg
27.18 kg/m^2
STANDARD_DEVIATION 5.505 • n=3 Participants • BMI not available for one participant in DC-A 48 mg
29.01 kg/m^2
STANDARD_DEVIATION 5.201 • n=5 Participants • BMI not available for one participant in DC-A 48 mg
33.99 kg/m^2
STANDARD_DEVIATION 6.138 • n=4 Participants • BMI not available for one participant in DC-A 48 mg
32.58 kg/m^2
STANDARD_DEVIATION 6.447 • n=3 Participants • BMI not available for one participant in DC-A 48 mg
25.91 kg/m^2
STANDARD_DEVIATION 1.557 • n=4 Participants • BMI not available for one participant in DC-A 48 mg
29.74 kg/m^2
STANDARD_DEVIATION 6.805 • n=4 Participants • BMI not available for one participant in DC-A 48 mg
30.25 kg/m^2
STANDARD_DEVIATION 6.699 • n=4 Participants • BMI not available for one participant in DC-A 48 mg
27.54 kg/m^2
STANDARD_DEVIATION 0.825 • n=3 Participants • BMI not available for one participant in DC-A 48 mg
34.87 kg/m^2
n=1 Participants • BMI not available for one participant in DC-A 48 mg
28.1 kg/m^2
STANDARD_DEVIATION 3.763 • n=8 Participants • BMI not available for one participant in DC-A 48 mg
26.05 kg/m^2
STANDARD_DEVIATION 4.183 • n=17 Participants • BMI not available for one participant in DC-A 48 mg
28.13 kg/m^2
STANDARD_DEVIATION 2.523 • n=6 Participants • BMI not available for one participant in DC-A 48 mg
28.34 kg/m^2
STANDARD_DEVIATION 3.670 • n=8 Participants • BMI not available for one participant in DC-A 48 mg
28.54 kg/m^2
STANDARD_DEVIATION 4.895 • n=74 Participants • BMI not available for one participant in DC-A 48 mg
Median Body Mass Index
25.26 kg/m^2
n=2 Participants • BMI not available for one participant in DC-A 48 mg
38.54 kg/m^2
n=2 Participants • BMI not available for one participant in DC-A 48 mg
27.8 kg/m^2
n=3 Participants • BMI not available for one participant in DC-A 48 mg
29.24 kg/m^2
n=5 Participants • BMI not available for one participant in DC-A 48 mg
32.83 kg/m^2
n=4 Participants • BMI not available for one participant in DC-A 48 mg
29.49 kg/m^2
n=3 Participants • BMI not available for one participant in DC-A 48 mg
25.98 kg/m^2
n=4 Participants • BMI not available for one participant in DC-A 48 mg
29.02 kg/m^2
n=4 Participants • BMI not available for one participant in DC-A 48 mg
29.62 kg/m^2
n=4 Participants • BMI not available for one participant in DC-A 48 mg
27.53 kg/m^2
n=3 Participants • BMI not available for one participant in DC-A 48 mg
34.87 kg/m^2
n=1 Participants • BMI not available for one participant in DC-A 48 mg
27.09 kg/m^2
n=8 Participants • BMI not available for one participant in DC-A 48 mg
25.81 kg/m^2
n=17 Participants • BMI not available for one participant in DC-A 48 mg
27.66 kg/m^2
n=6 Participants • BMI not available for one participant in DC-A 48 mg
29.38 kg/m^2
n=8 Participants • BMI not available for one participant in DC-A 48 mg
27.69 kg/m^2
n=74 Participants • BMI not available for one participant in DC-A 48 mg
Mean PSA
37.295 ng/mL
STANDARD_DEVIATION 17.9534 • n=2 Participants
96.855 ng/mL
STANDARD_DEVIATION 132.7452 • n=2 Participants
10.383 ng/mL
STANDARD_DEVIATION 7.8450 • n=3 Participants
8.996 ng/mL
STANDARD_DEVIATION 7.0365 • n=5 Participants
90.718 ng/mL
STANDARD_DEVIATION 87.1840 • n=4 Participants
6.280 ng/mL
STANDARD_DEVIATION 4.7483 • n=3 Participants
149.423 ng/mL
STANDARD_DEVIATION 157.4893 • n=4 Participants
34.766 ng/mL
STANDARD_DEVIATION 10.52727 • n=4 Participants
53.404 ng/mL
STANDARD_DEVIATION 21.9723 • n=4 Participants
24.433 ng/mL
STANDARD_DEVIATION 5.2254 • n=3 Participants
12.720 ng/mL
n=1 Participants
38.358 ng/mL
STANDARD_DEVIATION 41.2016 • n=9 Participants
167.043 ng/mL
STANDARD_DEVIATION 274.6941 • n=17 Participants
112.449 ng/mL
STANDARD_DEVIATION 185.2442 • n=6 Participants
88.141 ng/mL
STANDARD_DEVIATION 78.4200 • n=8 Participants
84.364 ng/mL
STANDARD_DEVIATION 156.2876 • n=75 Participants
Median PSA
37.295 ng/mL
n=2 Participants
96.855 ng/mL
n=2 Participants
8.090 ng/mL
n=3 Participants
10.449 ng/mL
n=5 Participants
90.850 ng/mL
n=4 Participants
5.500 ng/mL
n=3 Participants
130.866 ng/mL
n=4 Participants
29.881 ng/mL
n=4 Participants
53.697 ng/mL
n=4 Participants
23.722 ng/mL
n=3 Participants
12.720 ng/mL
n=1 Participants
25.600 ng/mL
n=9 Participants
29.750 ng/mL
n=17 Participants
52.043 ng/mL
n=6 Participants
87.518 ng/mL
n=8 Participants
28.700 ng/mL
n=75 Participants
ECOG performance status
0
1 Participants
n=2 Participants
1 Participants
n=2 Participants
2 Participants
n=3 Participants
4 Participants
n=5 Participants
3 Participants
n=4 Participants
3 Participants
n=3 Participants
1 Participants
n=4 Participants
3 Participants
n=4 Participants
1 Participants
n=4 Participants
1 Participants
n=3 Participants
1 Participants
n=1 Participants
6 Participants
n=9 Participants
10 Participants
n=17 Participants
4 Participants
n=6 Participants
4 Participants
n=8 Participants
45 Participants
n=75 Participants
ECOG performance status
1
1 Participants
n=2 Participants
1 Participants
n=2 Participants
1 Participants
n=3 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=3 Participants
3 Participants
n=4 Participants
1 Participants
n=4 Participants
3 Participants
n=4 Participants
2 Participants
n=3 Participants
0 Participants
n=1 Participants
3 Participants
n=9 Participants
7 Participants
n=17 Participants
2 Participants
n=6 Participants
4 Participants
n=8 Participants
30 Participants
n=75 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Day 1 thru Day 28)

Population: Participants in dose escalation

Determination of DLT was made during the first 28 days of treatment in the dose escalation phase. A DLT is defined as a clinically significant AE or laboratory abnormality that is considered possibly, probably, or definitely related to study drug. The MTD reflects the highest dose of ZEN003694 in combination with enzalutamide that did not cause a DLT in more than 1 of 6 patients. The RP2D is the recommended dose of ZEN003694 in combination with enzalutamide as determined in the dose confirmation phase of the study.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
For Dose Escalation: Incidence of Dose-limiting Toxicities (DLT) to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ZEN003694 in Combination With Enzalutamide.
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 to 30 days post last dose

Population: All participants

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity of AEs was graded based on the National Cancer Institute's Common Terminology for Adverse Events (V4.03). A serious adverse event (SAE) was any AE that was: fatal; life-threatening; required in-patient hospitalization or prolonged an existing hospitalization; disabling or incapacitating; a congenital anomaly or birth defect; or any other important medical event.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=21 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
n=31 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Decreased appetite
0 Participants
2 Participants
2 Participants
1 Participants
10 Participants
3 Participants
2 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Diarrhea
0 Participants
0 Participants
0 Participants
1 Participants
5 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Dizziness
0 Participants
0 Participants
0 Participants
1 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Nausea
0 Participants
7 Participants
2 Participants
3 Participants
17 Participants
3 Participants
2 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Photosensitivity
0 Participants
2 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Rash
0 Participants
0 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Rash maculopapular
0 Participants
3 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Taste disorder
0 Participants
0 Participants
1 Participants
1 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Thrombocytopenia
0 Participants
1 Participants
1 Participants
2 Participants
6 Participants
0 Participants
1 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Vision blurred
0 Participants
0 Participants
0 Participants
0 Participants
2 Participants
1 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Visual symptoms
3 Participants
12 Participants
4 Participants
6 Participants
17 Participants
4 Participants
2 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Vomiting
0 Participants
1 Participants
0 Participants
0 Participants
3 Participants
1 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Weight loss and abnormal weight loss
1 Participants
0 Participants
0 Participants
1 Participants
3 Participants
1 Participants
2 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Blood creatinine increased
0 Participants
0 Participants
2 Participants
0 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Constipation
0 Participants
1 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Dysgeusia
0 Participants
2 Participants
0 Participants
0 Participants
10 Participants
1 Participants
3 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Dyspepsia
0 Participants
1 Participants
0 Participants
0 Participants
2 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Fatigue
1 Participants
8 Participants
1 Participants
2 Participants
13 Participants
3 Participants
1 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Nasal congestion
0 Participants
0 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants
For Dose Escalation and Dose Confirmation: Incidence of Treatment-emergent Adverse Events (TEAE) and Treatment-related Serious Adverse Events (SAE)
Photopsia
0 Participants
1 Participants
0 Participants
0 Participants
3 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Screening up to 35 months

Population: Arms were combined to analyze efficacy based on Cohorts defined by protocol. Cohort A is defined as patients with prior progression on enzalutamide or apalutamide by PCWG2 criteria. Cohort B is defined as patients who were enzalutamide-naïve with prior progression on abiraterone by PCWG2 criteria.

The PSA response rate will be evaluated using PCWG2 criteria and defined as the proportion of patients with a PSA decline of at least 50%. Any change from baseline is confirmed by a second measurement at least 3 weeks later. PSA Response Rate will be evaluated using PCWG2 criteria and defined as following: Percentage change from baseline in PSA to 12 weeks post ZEN003694 dose. Only evaluate for patients with at least 12 weeks of treatment, the PSA assessment at 12 weeks (84 days +/-3 days) will be used; Maximum percent decrease in PSA from baseline that occurs at any point after treatment. Evaluable for all patients with post-baseline PSA. Arms will be combined to analyze efficacy in Cohort A and Cohort B.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=45 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=30 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Evaluate Prostate-specific Antigen (PSA) Response Rate by PCWG2 Criteria
4.4 percentage of participants
Interval 0.5 to 15.1
23.3 percentage of participants
Interval 9.9 to 42.3
—
—
—
—
—

SECONDARY outcome

Timeframe: Screening up to 35 months

Population: Arms were combined to analyze efficacy based on Cohorts defined by protocol. Cohort A is defined as patients with prior progression on enzalutamide or apalutamide by PCWG2 criteria. Cohort B is defined as patients who were enzalutamide-naïve with prior progression on abiraterone by PCWG2 criteria.

Tumor response will be evaluated using the PCWG2 criteria. Patients with measurable disease will be evaluated for clinical benefit as determined by tumor response using RECIST v1.1. Patients with non-measurable bone disease will be evaluated for progression based on the presence of any new lesions by bone scans. Radiographic tumor evaluation will be performed at screening and every 3 cycles or more frequently as determined by the investigator. Using the tumor response that is determined by the investigator, best overall response will be determined using RECIST v1.1. Best overall response is defined as the best response recorded from the start of treatment until disease progression or study exit. Arms will be combined to analyze efficacy in Cohort A and Cohort B.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=39 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=26 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Evaluate Radiographic Response Rate (Overall Response Rate) by PCWG2 Criteria
2.6 percentage of participants
Interval 0.1 to 13.5
3.8 percentage of participants
Interval 0.1 to 19.6
—
—
—
—
—

SECONDARY outcome

Timeframe: Screening up to 35 months

Population: Arms were combined to analyze efficacy based on Cohorts defined by protocol. Cohort A is defined as patients with prior progression on enzalutamide or apalutamide by PCWG2 criteria. Cohort B is defined as patients who were enzalutamide-naïve with prior progression on abiraterone by PCWG2 criteria.

Overall progression free survival (PFS) is determined using the PCWG2 criteria. Overall PFS is measured from screening until the time that disease progression (radiographic progressive disease or clinical deterioration) or death is documented, whichever occurs first. Arms will be combined to analyze efficacy in Cohort A and Cohort B.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=45 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=30 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Evaluate Overall Median Progression-free Survival by PCWG2 Criteria
4.7 months
Interval 3.5 to 9.0
6.2 months
Interval 4.6 to 7.9
—
—
—
—
—

SECONDARY outcome

Timeframe: Screening up to 35 months

Population: Arms were combined to analyze efficacy based on Cohorts defined by protocol. Cohort A is defined as patients with prior progression on enzalutamide or apalutamide by PCWG2 criteria. Cohort B is defined as patients who were enzalutamide-naïve with prior progression on abiraterone by PCWG2 criteria.

Radiographic progression-free survival (rPFS) is determined using the PCWG2 criteria to assess both soft-tissue and bone assessments. The rPFS is measured from screening until the time the first radiographic scan shows disease progression, or until the time of death, whichever occurs first. If radiographic disease progression is identified at the first on-treatment radiographic assessment at Cycle 3 Day 1 (8 weeks), radiographic progression must be confirmed by a second assessment 6 or more weeks later. Patients who do not progress radiographically or did not die prior to study exit are censored on the date of their last dose of ZEN003694. Arms will be combined to analyze efficacy in Cohort A and Cohort B.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=45 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=30 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Evaluate Median Radiographic Progression-Free Survival by PCWG2 Criteria
10.2 months
Interval 4.8 to 13.1
8.8 months
Interval 6.1 to 11.5
—
—
—
—
—

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose

Population: All Evaluable Participants

AUC(0-24h) is defined as the area under the curve (plasma concentration of drug over a 24-hour time period).

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=21 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
n=31 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Measure the Pharmacokinetic (PK) Parameter: AUC(0-24h) of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide.
ZEN003694 AUC(0-24h) Study Day 1
1001 ng*h/mL
Standard Error 494
985 ng*h/mL
Standard Error 374
2243 ng*h/mL
Standard Error 848
1966 ng*h/mL
Standard Error 1067
2424 ng*h/mL
Standard Error 1450
2153 ng*h/mL
Standard Error 1529
2119 ng*h/mL
Standard Error 1547
Measure the Pharmacokinetic (PK) Parameter: AUC(0-24h) of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide.
ZEN003694 AUC(0-24h) Study Day 15; C24 (24h) inputed with Day 15 C0 (pre-dose) for AUC calculations
867 ng*h/mL
Standard Error 651
1046 ng*h/mL
Standard Error 512
1487 ng*h/mL
Standard Error 871
1453 ng*h/mL
Standard Error 967
2138 ng*h/mL
Standard Error 946
2109 ng*h/mL
Standard Error 578
1641 ng*h/mL
Standard Error 704
Measure the Pharmacokinetic (PK) Parameter: AUC(0-24h) of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide.
ZEN003791 AUC(0-24h) Study Day 1
1335 ng*h/mL
Standard Error 659
1874 ng*h/mL
Standard Error 635
3344 ng*h/mL
Standard Error 1101
3277 ng*h/mL
Standard Error 1708
4090 ng*h/mL
Standard Error 1562
3712 ng*h/mL
Standard Error 2660
3815 ng*h/mL
Standard Error 2774
Measure the Pharmacokinetic (PK) Parameter: AUC(0-24h) of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide.
ZEN003791 AUC(0-24h) Study Day 15; C24 (24h) imputed with Day 15 C0 (pre-dose) for AUC calculations.
1234 ng*h/mL
Standard Error 606
2216 ng*h/mL
Standard Error 1187
2979 ng*h/mL
Standard Error 1583
2586 ng*h/mL
Standard Error 1265
4478 ng*h/mL
Standard Error 2449
5275 ng*h/mL
Standard Error 2369
3155 ng*h/mL
Standard Error 1858

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose; Cycle 1 Day 2: pre-dose; Cycle 1 Day 15: pre-dose, 0.25, 0.5, 1, 2, 4, 6 and 8 hours post-dose

Population: All Evaluable Participants

Cmax is defined as the maximum or peak plasma concentration of drug.

Outcome measures

Outcome measures
Measure
DE A+B - 36 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 48 mg ZEN003694 + Enzalutamide
n=21 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 60 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A+B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 72 mg ZEN003694 + Enzalutamide
n=6 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 96 mg ZEN003694 + Enzalutamide
n=31 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 120 mg ZEN003694 + Enzalutamide
n=4 Participants
Dose Escalation Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B - 144 mg ZEN003694 + Enzalutamide
n=3 Participants
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Measure the Pharmacokinetic (PK) Parameter: Cmax of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide
ZEN003791 Cmax Study Day 15
129 ng/mL
Standard Error 72
220 ng/mL
Standard Error 101
259 ng/mL
Standard Error 176
319 ng/mL
Standard Error 208
477 ng/mL
Standard Error 194
552 ng/mL
Standard Error 332
432 ng/mL
Standard Error 362
Measure the Pharmacokinetic (PK) Parameter: Cmax of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide
ZEN003791 Cmax Study Day 1
125 ng/mL
Standard Error 83
184 ng/mL
Standard Error 62
244 ng/mL
Standard Error 79
306 ng/mL
Standard Error 196
374 ng/mL
Standard Error 143
342 ng/mL
Standard Error 202
417 ng/mL
Standard Error 362
Measure the Pharmacokinetic (PK) Parameter: Cmax of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide
ZEN003694 Cmax Study Day 1
181 ng/mL
Standard Error 83
216 ng/mL
Standard Error 103
290 ng/mL
Standard Error 102
452 ng/mL
Standard Error 279
492 ng/mL
Standard Error 277
425 ng/mL
Standard Error 306
494 ng/mL
Standard Error 424
Measure the Pharmacokinetic (PK) Parameter: Cmax of ZEN003694 and ZEN003791 (Active Metabolite) Administered in Combination With Enzalutamide
ZEN003694 Cmax Study Day 15
184 ng/mL
Standard Error 128
236 ng/mL
Standard Error 119
289 ng/mL
Standard Error 204
392 ng/mL
Standard Error 278
484 ng/mL
Standard Error 189
458 ng/mL
Standard Error 305
457 ng/mL
Standard Error 330

Adverse Events

DE A+B 36 mg ZEN003694 + Enzalutamide

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

DE/DC A+B 48 mg ZEN003694 + Enzalutamide

Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths

DE A+B 60 mg ZEN003694 + Enzalutamide

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

DE A+B 72 mg ZEN003694 + Enzalutamide

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

DE/DC A+B 96 mg ZEN003694 + Enzalutamide

Serious events: 6 serious events
Other events: 31 other events
Deaths: 0 deaths

DE A+B 120 mg ZEN003694 + Enzalutamide

Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths

DE A+B 144 mg ZEN003694 + Enzalutamide

Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
DE A+B 36 mg ZEN003694 + Enzalutamide
n=4 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE/DC A+B 48 mg ZEN003694 + Enzalutamide
n=21 participants at risk
Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 60 mg ZEN003694 + Enzalutamide
n=6 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 72 mg ZEN003694 + Enzalutamide
n=6 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE/DC A+B 96 mg ZEN003694 + Enzalutamide
n=31 participants at risk
Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 120 mg ZEN003694 + Enzalutamide
n=4 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 144 mg ZEN003694 + Enzalutamide
n=3 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Infections and infestations
Enterococcal bacteraemia
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Infections and infestations
Intervertebral discitis
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Infections and infestations
Leptospirosis
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
1/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Infections and infestations
Proteus infection
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Infections and infestations
Pyelonephritis
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Infections and infestations
Urinary tract infection
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Musculoskeletal and connective tissue disorders
Pathological fracture
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Nervous system disorders
Spinal cord compression
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Nervous system disorders
Transient ischaemic attack
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Renal and urinary disorders
Haematuria
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Renal and urinary disorders
Acute kidney injury
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Gastrointestinal disorders
Nausea
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
1/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Blood and lymphatic system disorders
Disseminated intravascular coagulation
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Cardiac disorders
Myocardial ischaemia
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Eye disorders
Vision blurred
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
1/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants

Other adverse events

Other adverse events
Measure
DE A+B 36 mg ZEN003694 + Enzalutamide
n=4 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (36 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE/DC A+B 48 mg ZEN003694 + Enzalutamide
n=21 participants at risk
Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (48 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 60 mg ZEN003694 + Enzalutamide
n=6 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (60 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 72 mg ZEN003694 + Enzalutamide
n=6 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (72 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE/DC A+B 96 mg ZEN003694 + Enzalutamide
n=31 participants at risk
Dose Escalation + Dose Confirmation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (96 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 120 mg ZEN003694 + Enzalutamide
n=4 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (120 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
DE A+B 144 mg ZEN003694 + Enzalutamide
n=3 participants at risk
Dose Escalation - Cohorts A + B - Enzalutamide (160 mg) PO QD 14 days lead-in followed by the combination of ZEN003694 (144 mg) PO QD and enzalutamide (160 mg) PO QD in 28-day cycles.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
2/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
19.4%
6/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
1/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Eye disorders
Visual impairment
75.0%
3/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
57.1%
12/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
66.7%
4/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
100.0%
6/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
58.1%
18/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
100.0%
4/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
66.7%
2/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Eye disorders
Photosensitivity reaction
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.5%
2/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Eye disorders
Photopsia
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Gastrointestinal disorders
Nausea
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
7/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
2/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
50.0%
3/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
51.6%
16/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
75.0%
3/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
66.7%
2/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Gastrointestinal disorders
Diarrhea
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.1%
5/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Gastrointestinal disorders
Vomiting
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Gastrointestinal disorders
Constipation
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
4.8%
1/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
General disorders
Fatigue
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
42.9%
9/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
2/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
41.9%
13/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
75.0%
3/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
1/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.5%
2/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
2/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
32.3%
10/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
75.0%
3/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
66.7%
2/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Investigations
Weight decreased
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
66.7%
2/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Investigations
Blood creatinine increased
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
2/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Nervous system disorders
Dysgeusia
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.5%
2/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
32.3%
10/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
25.0%
1/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
100.0%
3/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Nervous system disorders
Dizziness
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Nervous system disorders
Taste disorder
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
16.7%
1/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.7%
3/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
Skin and subcutaneous tissue disorders
Rash maculopapular
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
9.5%
2/21 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/6 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
3.2%
1/31 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
0.00%
0/4 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants
33.3%
1/3 • For an event to be recorded as an AE, the onset must occur during or after the patient's first exposure to study drug and no later than 30 days after the last study drug dose. There is no limit on reporting SAEs considered reasonably related to ZEN003694.
Adverse events were collected in all participants

Additional Information

Zenith Study Team

Zenith Epigenetics Ltd

Phone: (415) 470-5600

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place