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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
Must not have
Previous chemotherapy or hormonal therapy for treatment of ovarian cancer
Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 112 days
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had chemotherapy or hormonal therapy for ovarian cancer.
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I have been diagnosed with Hepatitis B, C, or HIV.
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I am pre or perimenopausal and allergic to certain hormone treatments.
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I am currently hospitalized for an infection or another serious illness.
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I am not taking any medications that are not allowed in the study.
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I have a history of heart conditions.
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I have had a bone marrow or stem cell transplant.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical Benefit Rate (CBR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Fulvestrant
2011
Completed Phase 3
~3520
Abemaciclib
2019
Completed Phase 2
~1890

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,667 Previous Clinical Trials
3,228,473 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,763 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,388 Previous Clinical Trials
289,109,087 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
~2 spots leftby Sep 2025
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