Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer

NCT03643510 | Completed Phase 2 FDA Drug

• 1 other identifier: 18-107
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine the effectiveness of the combination of abemaciclib and fulvestrant in treating this type of cancer and to determine the types and severity of side effects caused by treatment with abemaciclib and fulvestrant.

Conditions

Adenocarcinoma of Endometrium

Keywords

Hormone Receptor Positive; Fulvestrant; Abemaciclib; 18-107

Outcome Measures

Primary Outcomes (1)

• objective response rate

  defined as the percentage of patients with complete response (CR) + partial response (PR)\]after initiating therapy. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).

  1 year

Study Arms (1)

Fulvestrant in Combination with Abemaciclib

EXPERIMENTAL

Eligible patients will take Abemaciclib 150 milligrams mg orally once every 12 hours on days 1-28. Fulvestrant will be dosed 500mg intramuscularly (IM) on days 1 and 15 during cycle 1 and then on Day 1 during subsequent cycles. Each cycle will be 28 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, or study termination.

Drug: Fulvestrant; Drug: Abemaciclib

Interventions

Fulvestrant DRUG

Fulvestrant will be dosed 500mg intramuscularly (IM) on days 1 and 15 during cycle 1 and then on Day 1 during subsequent cycles.

Fulvestrant in Combination with Abemaciclib

Abemaciclib DRUG

Abemaciclib 150 milligrams mg orally once every 12 hours on days 1-28.

Fulvestrant in Combination with Abemaciclib

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Endometrial Cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have signed an approved informed consent and authorization permitting release of personal information.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 AND Karnofsky Performance Status (KPS) ≥ 80
• Patients are not required to but may have received no more than two prior chemotherapeutic regimens for management of endometrial carcinoma (including adjuvant chemotherapy). Initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy.
• Chemotherapy administered in conjunction with primary radiation as a radiosensitizer WILL be counted as a systemic chemotherapy regimen.
• Patients are not required to but may have received a single line of prior hormonal therapy with either an antiestrogen, anti-progesterone (or combination) or an aromatase inhibitor. Patients may not have received more than 1 line of endocrine therapy. This will not count toward prior therapy total.
• Resolution of adverse effects of recent surgery, radiotherapy, chemotherapy, or hormonal therapy to Grade ≤1 prior to first study treatment with the exception of peripheral neuropathy and alopecia.
• Postmenopausal status due to either surgical or natural menopause. Post-menopausal status due to surgical/natural menopause requires at least 1 of the following:
• History of hysterectomy
• Prior bilateral oophorectomy
• Age ≥ 60
• Age ≤ 60 and amenorrheic for at least 12 months (in the absence of chemotherapy, hormonal therapy or ovarian suppression) and FSH and estradiol levels in the postmenopausal range.
• Have a negative serum pregnancy test at baseline (within 7 days prior to -initiation of treatment) and agree to use medically approved precautions to prevent pregnancy during the study and for 1 month following the last dose of Abemaciclib.
• For patients of childbearing potential, agreement to use two effective forms of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study and for 30 days after the last abemaciclib dose.
• Patients must agree to pre- and post-treatment tumor biopsies

You may not qualify if:

• Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study
• Patient who is experiencing a visceral crisis, lymphangitic disease spread, leptomeningeal carcinomatosis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease.
• Patients who have received prior treatment with fulvestrant, everolimus, temsirolimus, ridaforolimus or another mTor inhibitor, or any CDK4 and CDK6 inhibitor.
• Patients who have received an autologous or allogenic stem-cell transplant.
• Clinically significant history of liver disease, including cirrhosis and current alcohol abuse.
• Patients who have active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection
• Presence of positive test results for hepatitis B (hepatitis B surface antigen \[HBsAGg\] and/or total HB core antibody \[anti-HBc\]) or hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)
• Patients positive for anti-HBc are eligible only if also positive for HB surface antibody (anti-HBs) and polymerase chain reaction (PCR) assay is negative for HBV DNA.
• Patients positive for HCV antibody are eligible only if testing for HCV RNA is negative.
• Known HIV infection.
• Active autoimmune disease that is not controlled by nonsteroidal anti -inflammatory drugs.
• Pregnancy, lactation, breastfeeding.
• Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
• Major surgical procedure within 14 days prior to randomization, or significant traumatic injury within 28 days prior to Day 1 or anticipation of the need for major surgery during the course of study treatment.
• Have initiated biphosphonate or RANK ligand targeted agents (for example,denosumab) \<7 days prior to Cycle 1 Day 1

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Eli Lilly and Company: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Fulvestrant; abemaciclib

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Angela Green, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single arm study of combination CDK4 and CDK6 dual inhibitor Abemaciclib and selective estrogen receptor degrader Fulvestrant in hormone receptor positive recurrent endometrial carcinomas.

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 22, 2018
• Study Start: August 21, 2018
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (7)