Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-31 @ 3:13 PM
Study NCT ID:
NCT02020135
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2013-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-label Extension Study of PSMA ADC 2301 in mCRPC
Sponsor:
Progenics Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open-label Treatment Extension of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
Status:
COMPLETED
Status Verified Date:
2017-02
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:
None
Brief Summary:
PSMA ADC 2301EXT is an open-label study to further assess the anti-tumor activity as measured by radiographic imaging and biomarkers, safety and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in subjects with mCRPC. Subjects who have participated in the PSMA ADC 2301 study and who, in the opinion of the Principal Investigator are likely to benefit from continued treatment with PSMA ADC are eligible for the PSMA ADC 2301 extension study. Subjects who are benefiting from treatment may be able to receive up to an additional eight to sixteen doses (every 3 weeks) of PSMA ADC.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: