Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04581512




Registration number
NCT04581512
Ethics application status
Date submitted
16/09/2020
Date registered
9/10/2020
Date last updated
9/07/2024

Titles & IDs
Public title
Study to Evaluate the Safety and Tolerability of EP0042
Scientific title
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
Secondary ID [1] 0 0
EP0042-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Chronic Myelomonocytic Leukemia 0 0
Myelodysplastic Syndromes 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EP0042

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


Treatment: Drugs: EP0042
EP0042 Oral 20 mg 50 mg capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period.
Timepoint [1] 0 0
First cycle of treatment (28 Days)

Eligibility
Key inclusion criteria
General

1. Male or female patients aged = 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML
2. Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue
3. Ability to swallow and retain oral medication
4. Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening
6. 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
7. Patients with pathologically confirmed/documented AML or MDS, as defined by the 2022 European LeukaemiaNet (ELN) recommendations, or CMML, as defined by World Health Organization (WHO) criteria, who have relapsed from or are refractory to previous therapy and have failed all (or are not eligible for/intolerant to) available approved therapies for their disease.
8. Patients with relapsed/refractory FLT3 WT AML.
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

5.2 Core
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Patients with any of the following will not be included in the study:

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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Amsterdam
Country [2] 0 0
Netherlands
State/province [2] 0 0
Rotterdam
Country [3] 0 0
United Kingdom
State/province [3] 0 0
UK
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ellipses Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Taussig
Address 0 0
The Royal Marsden, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ayan Yusuf
Address 0 0
Country 0 0
Phone 0 0
+44 (0) 2037430992
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04581512