EP0057 in Combination With Olaparib in Advanced Ovarian Cancer

Part of paid clinical trials in Irvine, California.

Sponsor
Ellipses Pharma
Study ID
NCT04669002
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EP0057 — DRUG
    EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
  • Olaparib tablets — DRUG
    Olaparib is a PARP inhibitor (poly \[adenosine diphosphate-ribose\] polymerase inhibitor)

Study Details

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.

Key Dates

Start date
Dec 14, 2020
Status verified
Aug 2023
Primary completion
Feb 17, 2023
Completion
May 5, 2023

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2A Cohort 1
    Patients with advanced platinum resistant ovarian cancer who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy
  • Experimental: Phase 2A Cohort 2
    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

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Approximately 18 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of California IrvineIrvineCalifornia92687-
Florida Cancer Specialists and Research InstituteLady LakeFlorida32159-
Augusta UniversityAugustaGeorgia30912-
Massachusetts General HospitalBostonMassachusetts02114-
North Shore Hematology Oncology Associates PC DBA New York Cancer and Blood SpecialistsEast SetauketNew York11733-
University of Rochester Medical CenterRochesterNew York14642-
Duke Cancer CenterDurhamNorth Carolina27710-
Magee Women's Hospital of UPMCPittsburghPennsylvania15213-
Prisma Health Cancer InstituteGreenvilleSouth Carolina29606-
Sarah CannonNashvilleTennessee37203-
Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22903-

Find similar trials in Irvine, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of California Irvine· Irvine, CAFlorida Cancer Specialists and Research Institute· Lady Lake, FLAugusta University· Augusta, GAMassachusetts General Hospital· Boston, MANorth Shore Hematology Oncology Associates PC DBA New York Cancer and Blood Specialists· East Setauket, NYUniversity of Rochester Medical Center· Rochester, NY

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