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NCT00857545 · ClinicalTrials.gov registry record · Phase 2
OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission
A Phase 2 study, sponsored by Gynecologic Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 171
- Enrollment target
NCT00857545: Completed Phase 2 study, sponsored by Gynecologic Oncology Group.
NCT00857545 is a Phase 2 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 171 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00857545, a Phase 2 study, has completed, sponsored by Gynecologic Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 171 participants
- Enrollment target
Study Summary
This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Primary Outcome
Progression-free survival is the period of time from the date of randomization to the date of first clinical, biochemical, or radiological evidence of progression, death due to any cause or date of last contact, whichever occurs first. Progression is defined as increasing clinical, radiological or histological evidence of disease. Patients with progressing disease based on clinical or histologic basis (ie. biopsy) must also have CT scan of the abdomen and pelvis performed.
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Polyvalent Antigen-KLH Conjugate Vaccine
- BIOLOGICAL Saponin-based Immunoadjuvant OBI-821
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2010-07 |
| Phase | Phase 2 |
What the finished NCT00857545 record still lists
NCT00857545 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00857545 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00857545 about?
NCT00857545 is a clinical study titled "OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer in Second or Third Complete Remission". This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biolog...
What is the current status of trial NCT00857545?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 171 participants. The study started on 2010-07.
What interventions are being tested in trial NCT00857545?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Polyvalent Antigen-KLH Conjugate Vaccine (BIOLOGICAL), Saponin-based Immunoadjuvant OBI-821 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00857545?
This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00857545's enrollment target sits among peer trials
171 398th of 2000 higher than 1,602 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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