CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Letrozole +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02657928
NCT02657928Phase 2Completed

A Phase 2 Trial of Ribociclib (LEE011) and Letrozole in ER Positive Relapsed Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinomas, and Endometrial Cancers.

Mayo Clinic·interventional·Posted Jan 18, 2016·Updated Oct 26, 2021

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Letrozole, and 1 other intervention for Estrogen Receptor Positive and 5 related conditions. Completed, enrolled 40 participants across 3 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 18, 2016
Enrollment StartJul 8, 2016
Primary CompletionMay 21, 2018
Study CompletionOct 7, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.5 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Letrozoledrug

Given PO

Ribociclibdrug

Given PO