The Axcelsius Study: A Study of ONO-7475 in Patients with Acute Leukemias

  • STATUS
    Recruiting
  • sponsor
    ONO Pharmaceutical
Updated on 23 July 2021
cancer
remission
myeloid leukemia
acute leukemia
leukemia
induction chemotherapy
refractory acute myeloid leukemia (aml)
blast cells
venetoclax

Summary

What is the Axcelsius study? The Axcelsius study is a clinical research study being conducted to determine the safety and tolerability of the study drug called ONO-7475. ONO-7475 has been tested in AML patients and was confirmed safe and tolerable at a dose to be used in the study. Previous non-clinical research has found that the study drug may work well with an approved drug called venetoclax. The purpose of this study is to see whether the study drug and venetoclax can work together to slow down the growth of cells that cause acute myeloid leukemia (AML).

What is the study drug? The study drug (ONO-7475) is the investigational drug being studied. Investigational means that the study drug is not approved by the United States Food and Drug Administration (FDA) or any other regulatory drug agency to use for AML or any other disease. Study participants in this study will take the study drug with venetoclax, an approved drug . Venetoclax can help stop certain cancers, like AML, from getting worse. The study drug and venetoclax are both tablets taken daily by mouth as prescribed by the study doctor. They should be taken together with food and water.

Who can participate in the study? This study is for people who have received therapy for AML but have not responded to it, or whose AML has come back.

How long will study participation last? How long participants stay in the study depends on their disease and whether they respond and tolerate the study drug and venetoclax. Estimated study duration is 6 months. Participants can remain in the study as long as they are benefitting.

Description

What can study participants expect? If you qualify and decide to participate, you will take the study drug and venetoclax as directed by the study team. All participants are expected to follow directions from the study team and attend all visits at the study clinic. Participants will receive study tests that are often used as regular therapy for AML.

Details
Condition leukemia, Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Leukemia (Pediatric)
Clinical Study IdentifierTX261357
SponsorONO Pharmaceutical
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adequate renal and hepatic function
Eastern Cooperative Oncology Group (ECOG) performance status 0-2 i.e., from full activity without restriction (ECOG=0) to ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours (ECOG=2)
Sexually active female patients of childbearing potential and sexually active male patients must agree to use an effective method of birth control, during your participation in the study and for 4 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records
Patients with Relapsed or Refractory AML who have no standard-of-care options known to provide clinical benefit in patients with R/R AML
Life expectancy of at least 3 months
All patients must have measured Bone Marrow aspirate blast counts at Screening
All patients must have received 1 to 3 (inclusive) prior AML therapies after first diagnosis of AML

Exclusion Criteria

QTcF interval >470 msec or other significant ECG abnormalities
Patients with active central nervous system leukemia
Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or severe cirrhosis
Human immunodeficiency virus (HIV), active hepatitis B (HBV) or C (HCV) infection
Retinal disease (e.g., retinitis pigmentosa including Mertk mutations), retinal hemorrhage or any disorder which may inhibit follow up for retinal toxicity
Participation in another clinical trial with any investigational drug within 14 days or with any licensed drug within five half-lives, prior to the first ONO-7475 dosing or prior to the first venetoclax dosing
Serious intercurrent medical or psychiatric illness that will prevent participation or compliance with study procedures, including serious active infection (including COVID-19)
Prior AML therapy (non-experimental) within 14 days or 5 half-lives, whichever is longer, prior to the first venetoclax dosing and no residual toxicity from the prior therapy hindering of ONO-7475 plus venetoclax dosing
Acute promyelocytic leukemia (the French-American-British M3 classification)
Concurrent treatment with other investigational drugs
Proliferative disease (white blood cell [WBC] counts >25 x 10e9/L) confirmed prior to the first dose of ONO-7475
Daily requirement of ≥10 mg/day of prednisone or equivalent dose of other corticosteroids
Prior HSCT within 12 weeks of the first dose of study treatment or ongoing immunosuppressive therapy for graft-versus-host disease
Active malignancy, other than AML, requiring systemic therapy except for those patients who have been diagnosed with either prostate or breast cancer and who have received a stable dose of hormone therapy for a minimum of 6 months prior to entering this study
Known hypersensitivity to Venetoclax
Prior radiotherapy within 21 days of screening, with the exception of localized palliative radiotherapy
Patients undergoing current treatments for other cancers
Pregnant or lactating women
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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