RecruitingPhase 1Phase 2NCT04581512

Study to Evaluate the Safety and Tolerability of EP0042

A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies


Sponsor

Ellipses Pharma

Enrollment

70 participants

Start Date

Nov 2, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental oral drug called EP0042 in people with difficult-to-treat blood cancers, including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML), whose cancer has returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with AML, MDS, or CMML confirmed by pathology - Your cancer has returned (relapsed) or stopped responding (refractory) to prior treatments, and you have exhausted or are ineligible for other available therapies - You are in reasonable general health (ECOG performance status 0–2) - You are able to swallow pills - You have had your cancer's mutation status tested **You may NOT be eligible if...** - Your disease is well-controlled or in complete remission - You have serious uncontrolled medical conditions - You are unable to complete at least one 28-day treatment cycle - You are pregnant or breastfeeding - You have severe liver or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEP0042

EP0042 Oral 20 mg 50 mg capsules

DRUGVenetoclax

Venetoclax

DRUGAzacitidine (AZA)

Azacitidine


Locations(6)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04581512


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