A Phase 2 study to evaluate the safety and efficacy of EP0057 in combination with Olaparib in advanced ovarian cancer patients who have: Cohort 1 – platinum resistant disease and are PARP inhibitor naïve; Cohort 2 – had at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by PARP inhibitor maintenance

Ellipses Pharma Limited0 sites384 target enrollmentOctober 15, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced ovarian cancer patients who have: Cohort 1 – platinum resistant disease and are PARP inhibitor naïve
Sponsor: Ellipses Pharma Limited
Enrollment: 384
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

October 15, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Ellipses Pharma Limited

•Patients must meet all the following inclusion criteria to be eligible for inclusion in the study:
•1\. Patients age \=18 years of age at the time of informed consent
•2\. Ability to understand and provide written informed consent prior to undergoing any study procedures
•3\. Life expectancy of \> 3 months, as estimated by the investigator
•4\. Histologically confirmed diagnosis (cytology alone excluded) with highgrade serous ovarian cancer or high\-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer
•5\. BRCA mutational status is known (germline and somatic)(For patients in Phase 2A, status does not need to be known prior to enrollment).
•6\. HRD status is known ( For patients in Phase 2A, status does not need to be known prior to enrollment)
•7\. At least 1 measurable lesion to assess response by RECIST v1\.1 criteria
•8\. Archival tumour sample must be available. In the absence of an archival tumour biopsy, a tumour tissue biopsy will need to be collected prior to enrolment
•9\. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening

•1\. Non\-epithelial tumour of the ovary, the fallopian tube or the peritoneum
•2\. Ovarian tumours of low malignant potential or low grade
•3\. Prior treatment with a topoisomerase I inhibitor
•4\. Potent inhibitors or inducers of CYP3A4
•5\. Concurrent treatment with Coumadin (warfarin)
•6\. History of stroke, transient ischemic attack (TIA), or myocardial infarction, within 6 months prior to C1D1
•7\. Brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy. Brain imaging must not be older than 12 weeks (at the start of screening). Results with
•abnormal/unexpected findings of brain MRI should be discussed with the Medical Monitor as part of the screening process
•8\. Systemic anti\-cancer therapy for the disease under study within 3 weeks or 5 half\-lives, whichever is longer, of the first dose of study drug
•9\. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia or certain Grade 2 toxicities, which in the opinion of the Investigator should not exclude the patient.