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NCT01620515 · ClinicalTrials.gov registry record · Phase 2
Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer
A Phase 2 study of Prostate Cancer, sponsored by Nymox Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 141
- Enrollment target
- 20
- Study locations
NCT01620515: Completed Phase 2 study of Prostate Cancer, sponsored by Nymox Corporation.
NCT01620515 is a Phase 2 study of Prostate Cancer that has completed, run by Nymox Corporation. The registered enrollment target is 141 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01620515, a Phase 2 study of Prostate Cancer, has completed, sponsored by Nymox Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 141 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg or 15 mg) followed by active surveillance or to no treatment (continued active surveillance). Blinded efficacy evaluation will be by a second post-treatment prostate biopsy.
Primary Outcome
The primary efficacy endpoint is the percentage of subjects with undetectable prostate cancer (negative biopsy) in the region of the prostate where the baseline cancer was detected.
Conditions Studied
Interventions
- DRUG NX-1207 2.5 mg
- DRUG NX-1207 15 mg
Study Locations (20)
California
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Atherton
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - La Mesa
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Long Beach
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - San Diego
Colorado
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Denver
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Englewood
Florida
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Aventura
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Naples
Maryland
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Annapolis
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Baltimore
New York
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Garden City
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - New York
Arizona
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Tucson
Connecticut
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - New Britain
Indiana
- For information concerning this clinical site, please contact Nymox at 800-936-9669. - Jeffersonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 141 participants |
| Start Date | 2012-02-21 |
| Est. Completion | 2015-10-21 |
| Phase | Phase 2 |
What the finished NCT01620515 record still lists
NCT01620515 is an interventional study that assigns participants to a tested intervention. The registered 141 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 (77% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which NX-1207 2.5 mg is the first listed.
NCT01620515 names 20 study sites across 13 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01620515 about?
NCT01620515 is a clinical study titled "Two-Dose Level Evaluation of NX-1207 for the Treatment of Low Risk, Localized (T1c) Prostate Cancer". This study is designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low risk localized (T1c) prostate cancer in patients currently undergoing active surveillance. Study participants currently on active surveillance will be randomized eith...
What is the current status of trial NCT01620515?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 141 participants. The study started on 2012-02-21. Estimated completion is 2015-10-21.
What conditions does trial NCT01620515 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01620515?
The interventions under investigation include: NX-1207 2.5 mg (DRUG), NX-1207 15 mg (DRUG).
Who is sponsoring clinical trial NCT01620515?
This trial is sponsored by Nymox Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01620515 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. 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 NCT01620515's enrollment target sits among peer trials
141 278th of 735 higher than 458 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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