Study to Evaluate the Safety and Tolerability of EP0042

Sponsor
Ellipses Pharma
Study ID
NCT04581512
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • EP0042 — DRUG
    EP0042 Oral 20 mg 50 mg capsules
  • Venetoclax — DRUG
    Venetoclax
  • Azacitidine (AZA) — DRUG
    Azacitidine

Study Details

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).

Key Dates

Start date
Nov 2, 2020
Status verified
Oct 2025
Primary completion
Oct 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Module 1 EP0042
    Establishing the safety of EP0042 as a monotherapy and establishing an appropriate dose to take forward into subsequent modules.
  • Experimental: 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.

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period. [ Time Frame: First cycle of treatment (28 Days) ]

Central Contacts

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