Study to Evaluate the Safety and Tolerability of EP0042
NCT ID: NCT04581512
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
70 participants
INTERVENTIONAL
2020-11-02
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Module 1 EP0042
Establishing the safety of EP0042 as a monotherapy and establishing an appropriate dose to take forward into subsequent modules.
EP0042
EP0042 Oral 20 mg 50 mg capsules
Module 2 EP0042
* Part A: To evaluate the safety, tolerability, of EP0042 + a Bcl-2 inhibitor (venetoclax) in patients with R/R FLT3 wildtype (WT) AML.
* Part B: To evaluate the safety, tolerability, of EP0042 in combination with a Bcl 2 inhibitor (venetoclax) + a hypomethylating agent (azacitidine) in patients with R/R FLT3 WT or newly diagnosed AML.
EP0042
EP0042 Oral 20 mg 50 mg capsules
Venetoclax
Venetoclax
Azacitidine (AZA)
Azacitidine
Interventions
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EP0042
EP0042 Oral 20 mg 50 mg capsules
Venetoclax
Venetoclax
Azacitidine (AZA)
Azacitidine
Eligibility Criteria
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Inclusion Criteria
9. Previous exposure to venetoclax, hypomethylating agent and/or FLT3 inhibitors (gilteritinib, midostorin, quizartinib, sorafenib) is allowed for relapsed/refractory AML patients.
10. Mutation status of patients must be known at trial entry.
11. Female patients should either be of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening until 6 months following administration of the last dose of study drug
12. Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug
Exclusion Criteria
Disease Under Study and Prior Anticancer Treatment
1. Suspected brain and/or leptomeningeal metastases that are symptomatic or untreated or that require current therapy
2. Acute promyelocytic leukemia (FAB:M3)
3. Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. If the previous anti-cancer therapy has a very long half-life and may interact with EP0042, e.g. a strong CYP3A4 inhibitor, the washout period may need to be increased for safety reasons but will be no longer than 3 weeks (Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment)
4. Ongoing toxic manifestations of previous treatments that have not reduced to at least CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 treatment related toxicities, which in the opinion of the Investigator should not exclude the patient.
5. Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks
Laboratory Parameters
6. Patient with any out-of-range laboratory values defined as shown below.
• Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \< 50 mL/ min
7. Inadequate liver function as demonstrated by
* total serum bilirubin ≥ 1.5 times the upper limits of normal range (ULN) or
* ALT ≥3 times the ULN or
* AST ≥3 times the ULN or
* AST or ALT ≥5 times the ULN in the presence of liver involvement by leukemia
18 Years
ALL
No
Sponsors
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Ellipses Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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David Taussig
Role: PRINCIPAL_INVESTIGATOR
The Royal Marsden, UK
Locations
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Royal Perth Hospital
Perth, Western Australia, Australia
Amsterdam UMC
Amsterdam, Amsterdam, Netherlands
Erasmus MC
Rotterdam, Rotterdam, Netherlands
University College London Hospital
London, London, United Kingdom
The Royal Marsden
London, UK, United Kingdom
The Christie Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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David Taussig, Dr
Role: primary
Role: backup
Other Identifiers
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EP0042-101
Identifier Type: -
Identifier Source: org_study_id
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