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Brief Title: EP0057 in Combination With Olaparib in Advanced Ovarian Cancer
Official Title: Phase 2 Study to Evaluate the Safety & Efficacy of EP0057 in Combination With Olaparib in Advanced Ovarian Cancer Patients Who Have: Cohort 1 - Platinum Resistant Disease; 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
Study ID: NCT04669002
Brief Summary: EP0057-201 is a Phase 2A/B adaptive design study. Phase 2A will test EP0057 in combination with Olaparib and Phase 2B, the randomised part of the study, will test EP0057 in combination with Olaparib against SOC chemotherapy. When EP0057 is combined with Olaparib, it is envisaged that the combination should improve therapeutic responses in the recurrent ovarian cancer disease setting. EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.
Detailed Description: EP0057-201 is an adaptive Phase 2A/B study in patients with advanced ovarian cancer. Phase 2A Phase 2A will be comprised of 2 single-arm treatment cohorts: Cohort 1 will explore EP0057 in combination with Olaparib in patients with advanced platinum resistant ovarian cancer (see inclusion criteria for definition of platinum resistant) who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy (n\~=30) Cohort 2 will explore EP0057 in combination with Olaparib in patients with advanced ovarian cancer who have received at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by a PARP inhibitor as maintenance treatment as their last treatment regimen (n\~=30) It is anticipated that up to approximately 60 patients (approximately 30 patients per cohort) will be enrolled into Phase 2A. Both treatment cohorts will open in parallel and patients will be enrolled into each cohort concurrently. At the end of Phase 2A, the Safety Review Committee will guide the decision to initiate 1 or both cohorts in Phase 2B, or terminate further recruitment into the study. Phase 2B Phase 2B will be comprised of 2 treatment cohorts, each randomised versus SOC. One or both cohorts may be opened concurrently to recruitment: Cohort 1 will explore EP0057 in combination with Olaparib compared with SOC chemotherapy (TBC) in patients with advanced platinum resistant ovarian cancer who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy (n=\~132) Cohort 2 will explore EP0057 in combination with Olaparib compared with SOC chemotherapy (TBC) in patients with advanced ovarian cancer who have received at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by a PARP inhibitor as maintenance treatment as their last therapy (n=\~192) It is anticipated that \~324 patients will be enrolled into Phase 2B. Both treatment cohorts may open in parallel and patients may be enrolled into each cohort concurrently.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of California Irvine, Irvine, California, United States
Florida Cancer Specialists and Research Institute, Lady Lake, Florida, United States
Augusta University, Augusta, Georgia, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
North Shore Hematology Oncology Associates PC DBA New York Cancer and Blood Specialists, East Setauket, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Sarah Cannon, Nashville, Tennessee, United States
Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
St. Margit Hospital, Budapest, , Hungary
National Institute of Oncology, Budapest, , Hungary
University of Debrecen Clinical Center, Debrecen, , Hungary
Petz Aladár County Teaching Hospital, Győr, , Hungary
Royal Shrewsbury Hospital, Shrewsbury, Shropshire, United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
University College Hospital, London, , United Kingdom
Guy's Hospital, London, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Royal Stoke Hospital, Stoke-on-Trent, , United Kingdom