Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer (NCT05872204) | Clinical Trial Compass
RecruitingPhase 2
Abemaciclib and Letrozole in Patients With Estrogen Receptor-positive Rare Ovarian Cancer
Belgium, France100 participantsStarted 2023-11-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.
✓. 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 low-grade endometrioid carcinoma of ovary, fallopian tube or peritoneum or granulosa-cell tumor of the adult type and ER positivity on immunohistochemistry. In order to prevent inclusion of patients with high-grade serous carcinoma, diagnosis of low-grade serous carcinoma will be verified as part of screening review by a gynecologic pathologist. Tissue for confirmation can be from primary tumor or recurrence.
✓. 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 platinum is still an option will be included, with no limitations in prior chemotherapy regimens and a maximum of 2 prior endocrine therapy regimens. Fifteen patients where platinum is not an option are allowed with no limitations in prior chemotherapy regimens and maximum of 2 prior endocrine therapy regimens. Patients cannot have received chemotherapy for platinum resistant or refractory disease.
✓. 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 lesion must be ≥10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam or must be ≥20 mm when measured by chest x-ray. Lymph nodes must be \>15 mm in short axis when measured by CT or MRI.
Exclusion criteria
✕. 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 have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy).
✕. 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 impairment (e.g. estimated creatinine clearance \<30 mL/min), history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).
✕. 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).
What they're measuring
1
The overall response rate (ORR) of the combination of abemaciclib and letrozole, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Timeframe: Week 24
2
The overall response rate (ORR) of the combination of abemaciclib and letrozole, according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
✓. 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.