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New treatment option for Low Grade Serous Ovarian Carcinoma
Official title Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
ClinicalTrials.gov ID: NCT05872204
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for low grade serous ovarian carcinoma.
Also referred to as Verzenios.
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 purpose of this study is to assess the efficacy and safety of abemaciclib and letrozole for treatment of estrogen receptor-positive rare ovarian cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per...
- Histological confirmation of diagnosis of low-grade serous (original diagnosis of low-grade serous carcinoma or original diagnosis of serous...
- For Stage 1: only patients where platinum is still an option are eligible with no limitations in prior chemotherapy regimens and a maximum of 2 prior...
- Age \> 18 years at time of study entry.
You likely can't join if
- For Stage 1: patients where platinum is not an option and platinum refractory patients are not allowed. For Stage 2: patients with platinum...
- The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease...
- Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited...
- Diagnosis of another malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the...
- Patient cannot have previously received a prior cyclin dependent kinase inhibitor (CDKi).
- Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
See the full eligibility criteria
Who can join
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants...
- Histological confirmation of diagnosis of low-grade serous (original diagnosis of low-grade serous carcinoma or original diagnosis of serous borderline tumor with subsequent diagnosis of low-grade serous carcinoma )or...
- For Stage 1: only patients where platinum is still an option are eligible with no limitations in prior chemotherapy regimens and a maximum of 2 prior endocrine therapy regimens. For Stage 2: a further 20 patients where...
- Age \> 18 years at time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
- Patient must have recurrent, measurable disease by RECIST v1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least 1 dimension (longest dimension to be recorded). Each...
- Pre- and post-treatment tissue biopsy and ct-DNA blood sample are mandatory for translational studies. Tissue from an archival tissue sample or fresh tissue obtained from a core or excisional biopsy of a tumor lesion.
- Patients who were previously treated with letrozole or another aromatase inhibitor are allowed, but capped at 10 patients in each cohort.
- Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
- Patients must not have remaining ovarian function. In women who have at least one retained ovary, menopause must be confirmed with laboratory confirmation. Women who have ovarian function are eligible but must be placed...
- Abnormal organ function is permitted. However, patients must have:
- absolute neutrophil count ≥1500/mL
- platelets ≥100.000/mL
- hemoglobin ≥9 g/dL
- estimated creatinine clearance ≥ 45 ml/min as calculated using the method standard for the institution
- total serum bilirubin ≤1.5 X ULN
- aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≤3 X ULN
- alkaline phosphatase ≤2.5x ULN (or ≤5.0x ULN if liver or bone metastases)
What rules you out
- For Stage 1: patients where platinum is not an option and platinum refractory patients are not allowed. For Stage 2: patients with platinum refractory disease are not allowed. Patients who received chemotherapy must...
- The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal...
- Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Concomitant Medications section).
- Diagnosis of another malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Patient cannot have previously received a prior cyclin dependent kinase inhibitor (CDKi).
- Known Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) infection.
- Inability or unwillingness to swallow pills.
- Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
- Active infection requiring intravenous (IV) antibiotics or antifungals, or other uncontrolled recurrent illness requiring hospitalization.
- History of any of the following: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), sudden cardiac...
- Prior hematopoietic stem cell or bone marrow transplantation.
- Known history of brain metastasis(es) that may be considered active (screening imaging of brain is not required unless there is clinical suspicion of brain metastases). Patients with previously treated brain metastases...
- Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).
- Known or possible hypersensitivity to letrozole or abemaciclib or any of their excipients.
- Pre/perimenopausal women with a known hypersensitivity to gnRH (gonadotropin-releasing hormone) agonists.
- Patients who are pregnant or breastfeeding.
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device. The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is...
The study team makes the final eligibility decision.
Where it's taking place
- Liège, Liège, Belgium
- Ghent, Oost-Vlaanderen, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Strasbourg, Bas-Rhin, France
- Bordeaux, Gironde, France
- Toulouse, Haute-Garonne, France
- Saint-Herblain, Loire-Atlantique, France
- Lyon, Métropole de Lyon, France
- Paris, Île-de-France Region, France
- Groningen, Provincie Groningen, Netherlands
- Rotterdam, South Holland, Netherlands
- Utrecht, Utrecht, Netherlands
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 Liège, Liège, Belgium; Ghent, Oost-Vlaanderen, Belgium; Leuven, Vlaams-Brabant, Belgium; Strasbourg, Bas-Rhin, France; Bordeaux, Gironde, France; Toulouse, Haute-Garonne, France and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.