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NCT01420965 · ClinicalTrials.gov registry record · Phase 2
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
A Phase 2 study, sponsored by Augusta University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT01420965: Clinical Trial Phase 2 study, sponsored by Augusta University.
NCT01420965 is a Phase 2 study that was terminated before completion, run by Augusta University. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420965, a Phase 2 study, was terminated before completion, sponsored by Augusta University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-011 to boost its ability to kill cancer cells. The chemotherapy drug cyclophosphamide will also be given, either before or after the cells are collected at the start of the treatment. Objectives: \- To test the effectiveness of Sipuleucel-T, CT-011, and cyclophosphamide for prostate cancer. Eligibility: \- Men at least 18 years of age who have advanced prostate cancer. Design: * Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies. * This study has two parts, with different participants in each part. All participants will be monitored with frequent blood tests and imaging studies. * Part I: * Participants will provide cells for the Sipuleucel-T treatment three times. The first time will be 3 days before the chemotherapy. The second time will be 10 days after chemotherapy. The third time will be 24 days after chemotherapy. * Participants will have one dose of cyclophosphamide the day before the first dose of Sipuleucel-T. * Participants will have Sipuleucel-T about 3 days after each cell donation. * Part II: * Participants will be in three groups: Sipuleucel-T given alone, given with CT-011, or given with both cyclophosphamide and CT-011. * Participants will provide cells for the Sipuleucel-T treatment three times, as in Part I. * Participants will have Sipuleucel-T about 3 days after each cell donation, and will receive treatment with the other drugs as directed by the study doctors.
Interventions
- DRUG Cyclophosphamide
- DRUG CT-011 (Anti-PD1 Antibody)
- OTHER Sipuleucel-T (Provenge)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
Why NCT01420965 stopped before completion
NCT01420965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01420965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01420965 about?
NCT01420965 is a clinical study titled "Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer". Background: \- Sipuleucel-T is a new treatment for advanced stage prostate cancer. It takes cells from a person with prostate cancer and treats them in the laboratory. Then it returns the cells to the person to help the immune system fight the cancer. Sipuleucel-T may be combined with the drug CT-0...
What is the current status of trial NCT01420965?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01420965?
The interventions under investigation include: Cyclophosphamide (DRUG), CT-011 (Anti-PD1 Antibody) (DRUG), Sipuleucel-T (Provenge) (OTHER).
Who is sponsoring clinical trial NCT01420965?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01420965's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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