Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229366
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-03
Brief Title:
Ac-225-PSMA-62 Trial in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer
Sponsor:
POINT Biopharma a wholly owned subsidiary of Eli Lilly and Company
Organization:
POINT Biopharma a wholly owned subsidiary of Eli Lilly and Company
Study Overview
Official Title:
Ac-225-PSMA-62 Phase III Clinical Trial to Characterize Efficacy Safety Tolerability and Dosimetry in Oligometastatic Hormone Sensitive and Metastatic Castration Resistant Prostate Cancer ACCEL
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCEL
Brief Summary:
ACCEL is a multicenter open label phase IaIbII study of Ac-225-PSMA-62 in participants with prostate-specific membrane antigen PSMA-positive prostate cancer
Detailed Description:
The primary aim of the phase Ia study is to evaluate the safety and tolerability of Ac-225-PSMA-62 to determine the maximum tolerated dose MTD The primary aim of the randomized phase Ib dose optimization is to determine the recommended phase II doses RP2D for patients with mCRPC and OmHSPC The aim of the phase II study for patients with mCRPC is to evaluate the efficacy of Ac-225-PSMA-62
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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