Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05917470
Status:
TERMINATED
Last Update Posted:
2024-07-15
First Post:
2023-06-07
Brief Title:
A Clinical Study of ONCT-534 in Subjects with Metastatic Castration-resistant Prostate Cancer
Sponsor:
Oncternal Therapeutics Inc
Organization:
Oncternal Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Study of ONCT-534 in Subjects with Metastatic Castration-Resistant Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim Phase 1 results of ONCT-534 did not show clinically meaningful improvements of disease including prostate-specific antigen PSA levels in the 20 patients treated in eight dosing cohorts with various doses and schedules of administration
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A first-in-human clinical trial to test the investigational treatment ONCT-534 in participants with metastatic castration-resistant prostate cancer The main questions it aims to answer are
What are the most tolerable doses of ONCT-534 Phase 1
Does ONCT-534 have anti-tumor activity at tolerable doses Phase 2
This is a dose escalation and expansion study where participants will receive daily oral doses of ONCT-534
What are the most tolerable doses of ONCT-534 Phase 1
Does ONCT-534 have anti-tumor activity at tolerable doses Phase 2
This is a dose escalation and expansion study where participants will receive daily oral doses of ONCT-534
Detailed Description:
This is a Phase 12 multi-center study to investigate the safety tolerability and anti-tumor acitivity of ONCT-534 in patients with relapsed or refractory metastatic castration-resistant prostate cancer The study consists of 2 phases a Phase 1 Dose Escalation and a Phase 2 Dose Expansion
During the dose escalation in Phase 1 a group of participants will be assigned a certain dose level Once the dose level is considered safe the next group will be assigned a higher dose level The dose level may be raised or lowered depending on any safety events that occur throughout Phase 1 There will be approximately 27 participants enrolled in Phase 1 At the end of Phase 1 two dose levels will be chosen to be tested in Phase 2
During Phase 2 participants will be randomly assigned to 1 of the 2 dose levels chose in Phase 1 Approximately 16 participants will be enrolled in each of the 2 dose level groups for a total of 32 participants
During the dose escalation in Phase 1 a group of participants will be assigned a certain dose level Once the dose level is considered safe the next group will be assigned a higher dose level The dose level may be raised or lowered depending on any safety events that occur throughout Phase 1 There will be approximately 27 participants enrolled in Phase 1 At the end of Phase 1 two dose levels will be chosen to be tested in Phase 2
During Phase 2 participants will be randomly assigned to 1 of the 2 dose levels chose in Phase 1 Approximately 16 participants will be enrolled in each of the 2 dose level groups for a total of 32 participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None