Treatment
This study consists of two different treatment options:
- Avutometinib + Defactinib
- Standard therapy (Caelyx, Paclitaxel, Topotecan, Anastrazole or Letrozole)
Avutometinib is administered as a tablet twice per week.
Defactinib is administred as a tablet twice daily.
Caelyx is administered intravenously every 4 weeks.
Paclitaxel and Topotecan are administered intravenously on three subsequent weeks, followed by a week off.
Anastrazole and Letrozole are administered daily as a tablet.
The patient will be randomly allocated to one of the treatment groups. In case of randomization to the group receiving standard therapy the treating investigator will decide which of the drugs is best suited for the patient.
Treatment duration
The treatments are administered until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Histologically proven LGSOC (ovarian, fallopian, peritoneal)
- Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤1
Main exclusion criteria:
- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
- Co-existing high-grade ovarian cancer or another histology
- Prior treatment with avutometinib, defactinib, or other FAK inhibitors
- An active skin disorder that has required systemic therapy within one year of signing informed consent
- History of medically significant rhabdomyolysis
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06072781). 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