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Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma

NCT03531645 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-05

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if fulvestrant and abemaciclib can help to control low-grade serous ovarian cancer. The safety of this drug combination will also be studied.

This is an investigational study. Fulvestrant and abemaciclib are both FDA approved and commercially available for the treatment of several types of cancer. Their use in patients with low-grade serous ovarian cancer is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.

Conditions

  • Malignant Neoplasms of Female Genital Organs

Interventions

DRUG

Fulvestrant

Neoadjuvant Treatment (Cycles 1-4): Fulvestrant 500 mg injection in buttocks on Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4. Adjuvant Treatment (Cycles 5 and beyond): Fulvestrant 500 mg injection in buttocks on Day 1 of each cycle. Study cycle is 28 days.

DRUG

Abemaciclib

Neoadjuvant Treatment (Cycles 1-4): Abemaciclib 150 mg by mouth On Days 1-28 of each cycle. Adjuvant Treatment (Cycles 5 and beyond): On Days 1-28 of each cycle, you will take Abemaciclib 150 mg by mouth on Days 1-28 of each cycle. Study cycle is 28 days.

Sponsors & Collaborators

Principal Investigators

  • Amir A. Jazaeri, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-13
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03531645 on ClinicalTrials.gov