Treatment
In this trial two different treatments are combined:
- Abemaciclib (CDK4/6 inhibitor, tablets, 150mg, twice daily)
- Letrozole (aromatase inhibitor, tablets, 2,5mg, once daily)
Treatment duration
The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent
Eligibility
Main inclusion criteria:
- Diagnosis of low-grade serous or low-grade endometrioid carcinoma of ovary, fallopian tube or peritoneum or granulosa-cell tumor of the adult type and ER positivity on immunohistochemistry.
- For Stage 1: Patients where platinum is still an option and a maximum of 2 prior endocrine therapy regimens. For Stage 2: Maximum of 2 prior endocrine therapy regimens. Patients cannot have received chemotherapy for platinum resistant or refractory disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Recurrent, measurable disease by RECIST v1.1.
- Pre- and post-treatment tissue biopsy and ct-DNA blood sample are mandatory for translational studies.
Main 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 (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)
- Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers
- Patient cannot have previously received a prior cyclin dependent kinase inhibitor (CDKi)
- 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)
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT05872204). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be