Trial Outcomes & Findings for A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer. (NCT NCT05917470)
NCT ID: NCT05917470
Last Updated: 2024-12-11
Results Overview
Incidence of DLTs through Study Day 28
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Number of Participants with Dose Limiting Toxicities Through Study Day 28
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
Dose Level 1: 40mg QD
40mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
80mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
160mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
300mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
600mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
1200mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
160mg BID of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
300mg BID of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Safety Population
|
1
|
1
|
4
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
DLT-evaluable Pop
|
1
|
1
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
Efficacy-evaluable Population
|
1
|
1
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
4
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
STARTED
|
1
|
1
|
4
|
3
|
3
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Dose Level 1: 40mg QD
40mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
80mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
160mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
300mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
600mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
1200mg QD of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
160mg BID of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
300mg BID of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
1
|
2
|
3
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
0
|
2
|
1
|
3
|
3
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
Baseline characteristics by cohort
| Measure |
Dose Level 1: 40mg QD
n=1 Participants
40mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
n=1 Participants
80mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
n=4 Participants
160mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
n=3 Participants
300mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
n=3 Participants
1200mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
n=3 Participants
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
83 years
n=7 Participants
|
70.3 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
70.0 years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
76.0 years
STANDARD_DEVIATION 5.6 • n=8 Participants
|
67.7 years
STANDARD_DEVIATION 11.7 • n=8 Participants
|
74.0 years
STANDARD_DEVIATION 7.2 • n=24 Participants
|
69.8 years
STANDARD_DEVIATION 8.1 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=8 Participants
|
3 participants
n=8 Participants
|
2 participants
n=24 Participants
|
18 participants
n=42 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
0 participants
n=8 Participants
|
1 participants
n=24 Participants
|
3 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Number of Participants with Dose Limiting Toxicities Through Study Day 28Population: DLT-evaluable population
Incidence of DLTs through Study Day 28
Outcome measures
| Measure |
Dose Level 1: 40mg QD
n=1 Participants
40mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
n=1 Participants
80mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
n=3 Participants
160mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
n=3 Participants
300mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
n=3 Participants
1200mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
n=3 Participants
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities Through Study Day 28
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 51 WeeksPopulation: Efficacy-evaluable population
Proportion of patients who achieve at least a 50% drop in PSA from baseline (PSA50)
Outcome measures
| Measure |
Dose Level 1: 40mg QD
n=1 Participants
40mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
n=1 Participants
80mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
n=3 Participants
160mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
n=3 Participants
300mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
n=3 Participants
1200mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
n=3 Participants
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Reduction of Prostate-Specific Antigen (PSA) by More Than 50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
POST_HOC outcome
Timeframe: Up to 51 WeeksPopulation: Efficacy-evaluable Population
Any reduction in PSA after Baseline (First Day of Treatment)
Outcome measures
| Measure |
Dose Level 1: 40mg QD
n=1 Participants
40mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
n=1 Participants
80mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
n=3 Participants
160mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
n=3 Participants
300mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
n=3 Participants
1200mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
n=3 Participants
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
n=3 Participants
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Post-Baseline Decrease in PSA
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Dose Level 1: 40mg QD
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Dose Level 2: 80mg QD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Level 3: 160mg QD
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Dose Level 4: 300mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 5: 600mg QD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 6: 1200 mg QD
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
BID Dose Level 1: 160 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BID Dose Level 2: 300 mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1: 40mg QD
n=1 participants at risk
40mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
n=1 participants at risk
80mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
n=4 participants at risk
160mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
n=3 participants at risk
300mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
n=3 participants at risk
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
n=3 participants at risk
1200mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
n=3 participants at risk
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
n=3 participants at risk
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 2 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Blood and lymphatic system disorders
Atypical Haemolytic Uraemic Syndrome
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Eye disorders
Retinal Artery Occlusion
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
Other adverse events
| Measure |
Dose Level 1: 40mg QD
n=1 participants at risk
40mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 2: 80mg QD
n=1 participants at risk
80mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 3: 160mg QD
n=4 participants at risk
160mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 4: 300mg QD
n=3 participants at risk
300mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 5: 600mg QD
n=3 participants at risk
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
Dose Level 6: 1200 mg QD
n=3 participants at risk
1200mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 1: 160 mg BID
n=3 participants at risk
600mg of single agent ONCT-534 to be administered daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
BID Dose Level 2: 300 mg BID
n=3 participants at risk
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
ONCT-534: ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
General disorders
Fatigue
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
50.0%
2/4 • Number of events 2 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Vascular disorders
Flushing
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Vascular disorders
Hot Flush
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Nervous system disorders
Lumbroscral Plexopathy
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Nervous system disorders
Paresthesia
|
100.0%
1/1 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
50.0%
2/4 • Number of events 2 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
50.0%
2/4 • Number of events 2 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
25.0%
1/4 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
Blood Creatinine Increase
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extradural Neoplasm
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
General disorders
Oedema Peripheral
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
66.7%
2/3 • Number of events 2 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Cardiac disorders
Atrioventricular Block First Degree
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Investigations
Blood Creatinine Phophokinase Increased
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/4 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
0.00%
0/3 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
33.3%
1/3 • Number of events 1 • Up to 51 Weeks using the Safety Population
This is based on subjects treated with ONCT-534. 40mg QD (n=1); 80 mg QD (n=1); 160 mg QD (n=4); 300 mg QD (n=3); 600 mg QD (n=3); 1200 mg QD (n=3); 160 mg BID (n=3); 300 mg BID (n=3)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place