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Cyclin-dependent kinase (CDK) 4/6 inhibitor

Fulvestrant + Abemaciclib for Ovarian Cancer

Phase 2

Waitlist Available

Led By Amir A. Jazaeri, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histological diagnosis must be based on surgical or core biopsy not just fine needle aspiration. Biopsies performed at other institutions must undergo pathology review and confirmation at MD Anderson Cancer Center

Patients with clinical or surgical stage III or IV low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas who are unlikely to achieve optimal surgical cytoreduction and have been recommended to receive neoadjuvant therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 112 days

Awards & highlights

Study Summary

This trial is studying a combination of drugs as a possible treatment for low-grade serous ovarian cancer.

Who is the study for?

This trial is for women over 18 with advanced low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas who have measurable disease and are recommended to receive neoadjuvant therapy. Participants must be in good physical condition (ECOG PS 0-1), not pregnant, willing to use birth control, and able to undergo a biopsy. They should not have received prior treatment for ovarian cancer.Check my eligibility

What is being tested?

The study tests the effectiveness of fulvestrant combined with abemaciclib in controlling low-grade serous ovarian cancer. Both drugs are FDA approved for other cancers but their combination is investigational here. All participants at MD Anderson will receive this drug combo and provide tissue samples for research.See study design

What are the potential side effects?

Potential side effects include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver function alterations, potential allergic reactions to the drugs' components, and issues related to hormone level changes due to goserelin administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer diagnosis was confirmed with a biopsy, not just a needle aspiration.

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I have advanced low-grade ovarian, peritoneal, or fallopian tube cancer and was advised to get therapy before surgery.

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I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.

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I am willing to take goserelin if I am pre or perimenopausal.

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I am fully active or can carry out light work.

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I can provide a tissue sample from my tumor for testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 112 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~112 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 112 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Benefit Rate (CBR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fulvestrant + AbemaciclibExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1710

Fulvestrant

2011

Completed Phase 3

~3690

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor

2,622 Previous Clinical Trials

3,216,757 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,976 Previous Clinical Trials

1,789,490 Total Patients Enrolled

AstraZenecaIndustry Sponsor

4,274 Previous Clinical Trials

288,613,346 Total Patients Enrolled

Media Library

Abemaciclib (Cyclin-dependent kinase (CDK) 4/6 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03531645 — Phase 2

Cervical Cancer Research Study Groups: Fulvestrant + Abemaciclib

Cervical Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03531645 — Phase 2

Abemaciclib (Cyclin-dependent kinase (CDK) 4/6 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03531645 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Fulvestrant as an effective treatment?

"Our team has assessed the safety of Fulvestrant to be a 2, as this is currently only in Phase 2 testing and there are limited results verifying its efficacy."

Answered by AI

What is the current enrollment for this clinical research program?

"This trial has ceased recruitment efforts, having been first posted on August 13th 2019 and lastly edited on May 5th 2022. However, there are currently 4702 trials looking for individuals with genital neoplasms who identify as female in addition to 204 studies recruiting patients using fulvestrant treatments."

Answered by AI

Has Fulvestrant been previously employed in other research trials?

"As of today, 204 clinical trials are exploring the potential effects of Fulvestrant and 41 have entered their third phase. This medication is being tested at 9763 sites across the globe with particular focus on Alicante, Pamplona/Iruña."

Answered by AI

Is there availability for participants in this research initiative?

"This specific trial, which was initially made available on the 13th of August 2019, is no longer recruiting participants. Nevertheless, 4906 other clinical trials are actively enrolling patients at present."

Answered by AI