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NCT01695044 · ClinicalTrials.gov registry record · Phase 2
A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 2 study of Prostate Cancer, sponsored by Progenics Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
- 20
- Study locations
NCT01695044: Completed Phase 2 study of Prostate Cancer, sponsored by Progenics Pharmaceuticals.
NCT01695044 is a Phase 2 study of Prostate Cancer that has completed, run by Progenics Pharmaceuticals. The registered enrollment target is 119 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01695044, a Phase 2 study of Prostate Cancer, has completed, sponsored by Progenics Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
- 20
- Study locations
Study Summary
PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have received at least one taxane-containing chemotherapy regimen (e.g. docetaxel, cabazitaxel). The second group comprises subjects who are cytotoxic chemotherapy-naïve. Subjects who are cytotoxic chemotherapy-naïve must have received and progressed on-, be ineligible for, refused, have an intolerance to-, or not have access to Radium-223. Both groups of subjects must also have received and progressed on abiraterone acetate and/or enzalutamide. If a subject is unable to receive abiraterone acetate and/or enzalutamide, Sponsor approval is required for participation in the study. Subjects will receive up to eight doses of PSMA ADC approximately once every three weeks.
Primary Outcome
Total serum prostate-specific antigen (PSA) response was defined as any decrease from baseline of at least 30% or 50%.
Conditions Studied
Interventions
- DRUG PSMA ADC
Study Locations (20)
California
- - Burbank
- - Encinitas
- - Los Angeles
- - San Diego
Maryland
- - Baltimore
- - Baltimore
- - Rockville
Connecticut
- - New Haven
- - Norwalk
Alabama
- - Birmingham
Arizona
- - Tucson
Colorado
- - Denver
Florida
- - Port Saint Lucie
Hawaii
- - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT01695044 record still lists
NCT01695044 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which PSMA ADC is the first listed.
NCT01695044 names 20 study sites across 14 states, led by California, Maryland, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01695044 about?
NCT01695044 is a clinical study titled "A Study of PSMA ADC in Subjects With Metastatic Castration-resistant Prostate Cancer (mCRPC)". PSMA ADC 2301 is a Phase 2, open-label, study to assess the anti-tumor activity and tolerability of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in two groups of subjects with metastatic castration-resistant prostate cancer (mCRPC). One group comprises subjects who must have...
What is the current status of trial NCT01695044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2012-09. Estimated completion is 2015-02.
What conditions does trial NCT01695044 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01695044?
The interventions under investigation include: PSMA ADC (DRUG).
Who is sponsoring clinical trial NCT01695044?
This trial is sponsored by Progenics Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01695044 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01695044's enrollment target sits among peer trials
119 310th of 735 higher than 426 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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