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New treatment option for Endometrial Cancer
Official title A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
ClinicalTrials.gov ID: NCT07209449
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for endometrial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The researchers are doing this study to find out whether elacestrant is an effective and safe treatment alone or in combination with abemaciclib for people with advanced or recurrent ER+ endometrial cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥18 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have received previous platinum-based chemotherapy
- Patients may have received no more than 2 prior lines of therapy for management of endometrial carcinoma. This includes platinum-based chemotherapy...
- Patients may have received a maximum of one prior line of endocrine therapy for management of endometrial carcinoma but no prior oral SERD such as...
You likely can't join 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...
- Patient who is experiencing a visceral crisis, lymphangitic disease spread, leptomeningeal carcinomatosis. Visceral crisis is not the mere presence...
- Patients who have received prior treatment with elacestrant or other oral SERD, everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor, or...
- Patients with hyperlipidemia that is not adequately controlled.
- Patients with history of interstitial lung disease (ILD)/pneumonitis or evidence of ILD/pneumonitis on baseline imaging.
- Uncontrolled significant active infections. °HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months...
See the full eligibility criteria
Who can join
- Age ≥18 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients must have received previous platinum-based chemotherapy
- Patients may have received no more than 2 prior lines of therapy for management of endometrial carcinoma. This includes platinum-based chemotherapy alone or combined with a PD-1 inhibitor, small molecule agents, hormone...
- Patients may have received a maximum of one prior line of endocrine therapy for management of endometrial carcinoma but no prior oral SERD such as elacestrant.
- No prior treatment with a CDK4/6 inhibitor
- Measurable disease per RECIST v 1.1 criteria °Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented, or a biopsy is obtained to confirm persistence of...
- Advanced or recurrent endometrial carcinoma that is refractory to curative therapy.
- Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, de-differentiated, clear cell adenocarcinoma, mixed epithelial...
- Patient must have ER-positive tumor status either from the most recent sample of advanced/recurrent disease or from an archival tissue. °Documentation of ER-positive tumor with ≥ 1% staining by IHC as defined in the...
- p53 wt by IHC or TP53 wt by next generation sequencing platform either from the most recent sample of advanced/recurrent disease or from an archival tissue.
- No known dMMR or POLE mutation
- If MSK IMPACT mutational profiling or mutational profiling performed in a CLIA laboratory is not already performed, must have tissue available for MSK IMPACT molecular profiling to be performed clinically
- Female patients may be either postmenopausal or premenopausal or perimenopausal. Postmenopausal status is defined by:
- Age ≥ 60 years
- Age \ 40 mIU/mL and an estradiol value \<40 pg/mL or in postmenopausal ranges per local reference ranges
- Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy.
- Premenopausal or perimenopausal patients must be concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist for ovarian suppression starting at least 4 weeks before the start of trial therapy and continue...
- The effects of elacestrant and abemaciclib on the developing human fetus are unknown. For this reason and because SERDs and CDK4/6 inhibitors as well as other therapeutic agents used in this trial are known to be...
- Any prior radiotherapy directed at the malignant tumor must be discontinued prior to first study treatment. Patients who received radiotherapy must have completed and fully recovered from the acute effects of...
- Have adequate laboratory values as defined below: °Hematologic
- Absolute neutrophil count ≥1500/mm3 (≥1.5 × 10\^3/μL)
- Platelets ≥100,000/μL
- Hemoglobin ≥9.0 g/dL °Renal
- Creatinine clearance (CrCL) Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula °Hepatic
- Total bilirubin ≤1.5 ×ULN (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
- AST and ALT ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)
- Coagulation Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless abnormalities are unrelated...
- Serum Albumin Serum albumin ≥3.0 g/dL (≥30 g/L)
What rules you out
- 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 not...
- 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...
- Patients who have received prior treatment with elacestrant or other oral SERD, everolimus, temsirolimus, ridaforolimus or another mTOR inhibitor, or any CDK4 and CDK6 inhibitor
- Patients with hyperlipidemia that is not adequately controlled.
- Patients with history of interstitial lung disease (ILD)/pneumonitis or evidence of ILD/pneumonitis on baseline imaging.
- Uncontrolled significant active infections. °HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. control). Patients with a history of...
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral...
- Females who are pregnant or nursing. If with childbearing potential, should have a negative urine pregnancy test at the time of screening.
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen.
- Major surgery within 4 weeks of randomization
- Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition.
- Known intolerance to either study drug or any of the excipients.
- Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the patient's participation in a clinical study.
- Uncontrolled hypomagnesemia or hypokalemia, defined as values below the lower limit of normal despite optimal electrolyte supplementation or management
- Known untreated or active central nervous system (CNS) metastases (progression or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible...
- Presence of measurable disease outside the CNS
- No radiographic evidence of worsening upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
- No history of intracranial hemorrhage or spinal cord hemorrhage
- No ongoing requirement for dexamethasone as therapy for CNS disease (anticonvulsants at a stable dose are allowed)
- Screening CNS radiographic study is within 6 months after most recent intervention for CNS metastases and greater than 4 months after discontinuation of corticosteroids
- Inability to comply with study and follow-up procedures
- Patient is currently receiving or received any of the following medications prior to first dose of trial therapy:
- Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or 5 half-lives, whichever is shorter, prior to initiating study therapy.
- Herbal preparations/medications. These include, but are not limited to, St.John's wort, kava, ephedra (ma huang), ginkgo biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 21 days prior to...
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.