Ovarian CancerPhase 2NCT04669002
EP0057 in Combination With Olaparib in Advanced Ovarian Cancer
A Phase 2 study testing EP0057 and Olaparib tablets in people with Ovarian Cancer, run by Ellipses Pharma at 21 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- EP0057 and Olaparib tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 14 Dec 2020to 5 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years of age at the time of Informed Consent
- Ability to understand and provide written informed consent prior to undergoing any study procedures
- Life expectancy of > 3 months, as estimated by the investigator
- Histologically confirmed diagnosis (cytology alone excluded) with high-grade serous ovarian cancer or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer
- BRCA mutational status is known (germline and somatic). (For Patients in Phase 2A, status does not need to be known prior to enrolment)
- HRD status is known. (For Patients in Phase 2A, status does not need to be known prior to enrolment)
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- At least 1 measurable lesion to assess response by RECIST v1.1 criteria
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening
- Normal organ and bone marrow function:
- Haemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count (ANC) ≥ 1.5 x 109
- Lymphocyte count ≥ 0.5 x 109
- Platelet count ≥ 100 x 109
- Total bilirubin ≤ 1.5 institutional upper limit normal (ULN)
- Serum albumin ≥ 2.5 g/dL
- AST and ALT ≤ 2.5 x ULN, unless liver metastases are present in which case they must be ≤ 5 x ULN
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 50 mL/min (calculated using the Cockroft-Gault formula) for patients with creatinine levels above institutional normal
- Patients not receiving anti-coagulant medication must have an INR of ≤ 1.5 and an aPTT ≤ 1.5 x ULN
- In the opinion of the Investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug
- Willing and able to participate in all required evaluations and procedures in this study protocol
- Contraception: Each female subject of childbearing potential must agree to use a highly effective method of contraception (i.e., a method with less than 1% failure rate per year [e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, vasectomized partner, or combined birth control pills]) from screening until 6 months after the last dose of EP0057 or Olaparib, whichever was taken last. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine pregnancy test within 24 hours prior to EP0057 dosing on Day 1 of each Cycle (and must not be lactating). Each female subject will be considered to be of childbearing potential unless she has been surgically sterilised by hysterectomy or bilateral tubal ligation/salpingectomy or has been postmenopausal for at least 1 year.
- Cohort 1 patients (Phase 2A and 2B) must be/have:
- Received no more than 1 prior line of therapy which must be platinum-based chemotherapy
- Primary Platinum Resistant after completion of first line platinum-based chemotherapy
- Cohort 2 patients (Phase 2A and 2B) must have:
- Received at least 1 prior line of treatment, 1 of which must be platinum-based chemotherapy
- Received a PARP inhibitor in the maintenance setting as their most recent treatment following a confirmed response by RECIST1.1 (CR or PR) to the last regimen which must be a platinum-based chemotherapy, with maintenance of response by PARP inhibitor lasting ≥ 6 months, with subsequent confirmed disease progression as defined by RECIST v1.1 criteria
Who cannot join
- Non-epithelial tumour of the ovary, the fallopian tube or the peritoneum
- Ovarian tumours of low malignant potential or low grade
- Prior treatment with a topoisomerase I inhibitor
- Potent inhibitors or inducers of CYP3A4
- Concurrent treatment with Coumadin (Warfarin)
- History of stroke, transient ischemic attack, or myocardial infarction, within 6 months prior to C1D1
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- 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
- 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
- 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
- Patients considered by the Investigator to be at a higher baseline risk for new onset cystitis
- Patients with a history, or features suggestive, of bone marrow dysplasia or myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
- Confirmed QTcF > 470 msec on screening ECG or congenital long QT syndrome
- Receiving an investigational anti-cancer treatment concurrently or within 3 weeks or 5 half-lives of either the parent drug or any active metabolite, whichever is longer, prior to the first dose of study drug
- Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
- Hypersensitivity to EP0057 or any of its excipients
- Known history of Human Immunodeficiency Virus infection (HIV) (testing is not required), active infection with SARS-CoV-2, hepatitis B virus (HBV) or hepatitis C virus (HCV) per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection. All patients should be tested for an active SARS-CoV-2 infection with an approved diagnostic test kit
- Malignant disease other than that being treated in this study, with the following exceptions:
- Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment
- Completely resected basal cell and squamous cell skin cancers
- Any malignancy considered to be indolent and that has never required therapy
- Completely resected carcinoma in situ of any type
- Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Any major surgical procedure (in the investigator's judgement) within 2 weeks of the first dose of study drug
- Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)
- Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to randomisation or patients who have not completely recovered previous radiotherapy (Grade ≥ 2) from the effects of previous radiotherapy
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Note: Patients with indwelling catheters (e.g.,PleurX) are allowed
- Hypersensitivity or intolerance (due to safety or other reasons) to PARP inhibitors
- Cohort 1 patients (Phase 2A and 2B) who:
- Have primary platinum refractory disease defined as progression during first line treatment with 4-6 cycles of platinum based chemotherapy
- Cohort 2 patients (Phase 2A and 2B) who:
- Progress within 6 months during PARP inhibitor maintenance treatment
- Progress after completion of PARP inhibitor maintenance treatment
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States11 sites
Augusta University
Augusta, Georgia, 30912
Massachusetts General Hospital
Boston, Massachusetts, 02114
Emily Couric Clinical Cancer Center
Charlottesville, Virginia, 22903
Duke Cancer Center
Durham, North Carolina, 27710
North Shore Hematology Oncology Associates PC DBA New York Cancer and Blood Specialists
East Setauket, New York, 11733
Prisma Health Cancer Institute
Greenville, South Carolina, 29606
University of California Irvine
Irvine, California, 92687
Florida Cancer Specialists and Research Institute
Lady Lake, Florida, 32159
Sarah Cannon
Nashville, Tennessee, 37203
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center
Rochester, New York, 14642
United Kingdom6 sites
Addenbrooke's Hospital
Cambridge, CB2 0QQ
University College Hospital
London, NW1 2PG
Guy's Hospital
London, SE1 9RT
Hammersmith Hospital
London, W12 0HS
Royal Shrewsbury Hospital
Shrewsbury, Shropshire, SY3 8XQ
Royal Stoke Hospital
Stoke-on-Trent, ST4 6QG
Hungary4 sites
St. Margit Hospital
Budapest, 1032
National Institute of Oncology
Budapest, 1122
University of Debrecen Clinical Center
Debrecen, 4032
Petz Aladár County Teaching Hospital
Győr, 9023
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- EP0057, Olaparib tablets
- Keywords
- EP0057, Olaparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP0057Drug
EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
Olaparib tabletsDrug
Also called Lynparza
Olaparib is a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor)
| Study group | Role | What they receive |
|---|---|---|
| Phase 2A Cohort 1 | Experimental | Patients with advanced platinum resistant ovarian cancer who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy Receives: Drug: EP0057; Drug: Olaparib tablets |
| Phase 2A Cohort 2 | Experimental | 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 Receives: Drug: EP0057; Drug: Olaparib tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Overall Response Rate as measured using RECIST1.1
Measured: Approximately 18 months
Number of patients with treatment emergent adverse events as assessed by NCI CTCAE version 5
Measured: Approximately 18 months
Number of patients with related treatment emergent adverse events as assessed by NCI CTCAE version 5
Measured: Approximately 18 months
Number of patients with serious adverse events
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start14 Dec 2020
- Primary completion17 Feb 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellipses Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669002
- Sponsor's protocol ID
- EP0057-201
- Status last verified
- Aug 2023
- First submitted
- 2 Dec 2020
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04669002
- Acronym / sponsor ID
- EP0057-201
- Conditions
- Ovarian Cancer
- Keywords
- EP0057, Olaparib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ellipses PharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 2A Cohort 1 | Experimental | Drug: EP0057, Drug: Olaparib tabletsPatients with advanced platinum resistant ovarian cancer who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy |
| Phase 2A Cohort 2 | Experimental | Drug: EP0057, Drug: Olaparib tabletsPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients aged ≥ 18 years of age at the time of Informed Consent
- Ability to understand and provide written informed consent prior to undergoing any study procedures
- Life expectancy of > 3 months, as estimated by the investigator
- Histologically confirmed diagnosis (cytology alone excluded) with high-grade serous ovarian cancer or high-grade endometrioid ovarian cancer, including primary peritoneal or fallopian tube cancer
- BRCA mutational status is known (germline and somatic). (For Patients in Phase 2A, status does not need to be known prior to enrolment)
Key exclusion criteria (32 listed)
- Non-epithelial tumour of the ovary, the fallopian tube or the peritoneum
- Ovarian tumours of low malignant potential or low grade
- Prior treatment with a topoisomerase I inhibitor
- Potent inhibitors or inducers of CYP3A4
- Concurrent treatment with Coumadin (Warfarin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP0057EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously | Drug | Phase 2A Cohort 1, Phase 2A Cohort 2 |
| Olaparib tabletsAlso: LynparzaOlaparib is a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor) | Drug | Phase 2A Cohort 1, Phase 2A Cohort 2 |
Primary outcome
Overall Response Rate (ORR)
Time frame: Approximately 18 months
Overall Response Rate as measured using RECIST1.1
Number of patients with treatment emergent adverse events as assessed by NCI CTCAE version 5
Time frame: Approximately 18 months
Number of patients with related treatment emergent adverse events as assessed by NCI CTCAE version 5
Time frame: Approximately 18 months
Number of patients with serious adverse events
Time frame: Approximately 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EP0057 and Olaparib tablets in people with Ovarian Cancer, run by Ellipses Pharma at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Approximately 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.