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NCT02657928 · ClinicalTrials.gov registry record · Phase 2
Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT02657928: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT02657928 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02657928, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells by blocking some enzymes needed for cell growth. Cancer cells that are estrogen receptor positive may need estrogen to grow. Letrozole lowers the amount of estrogen made by the body and this may stop the growth of tumor cells that need estrogen to grow. Giving ribociclib together with letrozole may be an effective treatment in patients with ovarian, fallopian tube, primary peritoneal, or endometrial cancer.
Primary Outcome
The percentage of patients who are progression-free at 12 weeks (PFS12) is defined as patients who are alive and progression free at 12 weeks. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. T
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Letrozole
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-07-08 |
| Est. Completion | 2020-10-07 |
| Phase | Phase 2 |
What the finished NCT02657928 record still lists
NCT02657928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02657928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02657928 about?
NCT02657928 is a clinical study titled "Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer". This phase II trial studies how well ribociclib and letrozole work in treating patients with estrogen receptor (ER) positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer that has returned (come back) after a period of improvement. Ribociclib may stop the growth of tumor cells b...
What is the current status of trial NCT02657928?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2016-07-08. Estimated completion is 2020-10-07.
What interventions are being tested in trial NCT02657928?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Letrozole (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT02657928?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02657928's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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