Study on Abemaciclib and Letrozole for Treating Endometrial Cancer
Sponsor: Gynecologic Oncology Group
ClinicalTrials ID:NCT04393285
This clinical trial is testing a combination of two drugs, Abemaciclib and Letrozole, to see if they can help control advanced, persistent, or returning endometrial cancer over six months. The treatment will continue unless there are unacceptable side effects, the cancer progresses, or the patient or doctor decides to stop.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study aims to find out if the combination of Abemaciclib and Letrozole can effectively manage advanced stage, persistent, or recurrent endometrial cancer. The trial will monitor patients for six months to see if the cancer stops progressing. Treatment will continue until there are unacceptable side effects, the cancer worsens, or the patient or doctor decides to stop.
Eligibility Criteria
Inclusion Criteria
- Have advanced, persistent, or recurrent endometrial cancer that cannot be cured by surgery or radiotherapy.
- Cancer must be confirmed by a biopsy or show progression on scans.
- Cancer must be of endometrioid type, based on previous tests.
- Must have at least one measurable tumor that can be tracked using scans.
- Previous chemotherapy is allowed under certain conditions, but no more than two prior systemic treatments.
- Must be able to swallow pills.
- Must be in good overall health with a performance status of 0 or 1.
- Must have adequate blood counts and organ function based on specific lab tests.
- Must be at least 18 years old.
- Women of childbearing potential must have a negative pregnancy test and use effective contraception during and after the study.
- Must sign an informed consent form to participate.
Exclusion Criteria
- Have previously taken any CDK4/6 inhibitor.
- Have certain types of endometrial cancer, such as clear cell or serous types.
- Have allergies to Abemaciclib or Letrozole.
- Have previously received hormonal therapy for endometrial cancer.
- Have another invasive cancer within the past five years, except for certain skin cancers.
- Are taking long-term steroids or immunosuppressive drugs.
- Have active infections or serious medical conditions that could interfere with the study.
- Have a history of heart disease or recent heart problems.
- Are pregnant or breastfeeding.
- Have cancer that has spread to the brain.
- Have HIV or gastrointestinal issues affecting drug absorption.
- Plan to receive live vaccines shortly before or during the study.
- Have active bleeding disorders or a history of blood clots without treatment.
- Are participating in another clinical trial or have recently taken investigational drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Center | 36604 | Mobile | Alabama |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Smillow Cancer Care at Greenwich | 06830 | Greenwich | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Sylvester Comprehensive Cancer Center-Lennar Foundation Medical Center | 33146 | Coral Gables | Florida |
| Sylevester Comprehensive Cancer Center-Deerfield Beach | 33442 | Deerfield Beach | Florida |
| UF Health Cancer Center | 32160 | Gainesville | Florida |
| University of Miami - Sylvester Cancer Center | 33136 | Miami | Florida |
| UT Health Tower | 33136 | Miami | Florida |
| Advent Health - Orlando | 32804 | Orlando | Florida |
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