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NCT01931046 · ClinicalTrials.gov registry record · Phase 1
Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer
A Phase 1 study of Localized Prostate Cancer, sponsored by Momotaro-Gene.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 3
- Study locations
NCT01931046: Completed Phase 1 study of Localized Prostate Cancer, sponsored by Momotaro-Gene.
NCT01931046 is a Phase 1 study of Localized Prostate Cancer that has completed, run by Momotaro-Gene. The registered enrollment target is 28 participants, below the 113-participant average among 6 other Localized Prostate Cancer trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01931046, a Phase 1 study of Localized Prostate Cancer, has completed, sponsored by Momotaro-Gene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer.
Primary Outcome
To define the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) for intratumoral injection (IT) of Ad5-SGE-REIC/Dkk-3 viral vector.
Conditions Studied
Interventions
- DRUG Ad5-SGE-REIC/Dkk3
Study Locations (3)
California
- UCSD Moores Cancer Center - San Diego
Massachusetts
- Brigham and Women's Hospital - Boston
Texas
- The Methodist Hospital Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2013-10 |
| Est. Completion | 2020-03 |
| Phase | Phase 1 |
What the finished NCT01931046 record still lists
NCT01931046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 113-participant average among 6 other Localized Prostate Cancer trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Localized Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Ad5-SGE-REIC/Dkk3 is the first listed.
NCT01931046 reports a single indexed study location in California, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT01931046 about?
NCT01931046 is a clinical study titled "Use of Recombinant Adenovirus Therapy to Treat Localized Prostate Cancer". The purpose of this study is to evaluate the safety and effectiveness of AD5-SGE-REIC/Dkk-3 in patients with localized prostate cancer.
What is the current status of trial NCT01931046?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2013-10. Estimated completion is 2020-03.
What conditions does trial NCT01931046 study?
This clinical trial studies the following conditions: Localized Prostate Cancer.
What interventions are being tested in trial NCT01931046?
The interventions under investigation include: Ad5-SGE-REIC/Dkk3 (DRUG).
Who is sponsoring clinical trial NCT01931046?
This trial is sponsored by Momotaro-Gene, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01931046 being conducted?
This trial has 3 study locations across California, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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