Study to Assess Safety Tolerability Pharmacokinetics and Antitumor Activity of AZD4573 in Relapsed/Refractory Haematological Malignancies

  • STATUS
    Recruiting
  • End date
    Mar 2, 2022
  • participants needed
    48
  • sponsor
    AstraZeneca
Updated on 1 October 2021
renal function
cancer
chronic lymphocytic leukemia
lymphoma
multiple myeloma
hodgkin's disease
chronic myelomonocytic leukemia
secondary aml
leukemia
lymphocytic leukemia
secondary acute myeloid leukemia
progressive disease
richter syndrome
azd4573

Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary antitumor activity of AZD4573 in subjects with relapsed or refractory haematological malignancies.

Details
Condition childhood ALL, Chronic myelomonocytic leukemia, Multiple Myeloma, Juvenile Myelomonocytic Leukemia, Acute myeloid leukemia, Lymphoproliferative Disorder, Chronic Lymphocytic Leukemia, B-Cell Lymphoma, T-Cell Lymphoma, Lymphocytic Leukemia, Chronic, Lymphoma, B-Cell, Acute Myelogenous Leukemia (AML), Richter Syndrome, High Risk Myelodysplastic Syndrome, Lymphocytic Leukemia, Acute, Relapsed or Refractory Haematological Malignancies Including, Richter's Syndrome, Richter's Transformation, Lymphoproliferative disorders, leukemia, acute lymphoblastic, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, b-cell small lymphocytic lymphoma, multiple myeloma (mm), acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelomonocytic leukaemia, cmml
Treatment AZD4573
Clinical Study IdentifierNCT03263637
SponsorAstraZeneca
Last Modified on1 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with histologically confirmed, relapsed or refractory haematological
malignancies. Patients will include but are not limited to the following: Arm
A : B-cell Non-Hodgkin lymphoma , T-cell Non-Hodgkin lymphoma , Small
lymphocytic lymphoma (SLL) , Multiple myeloma (MM) Arm B: CLL (chronic
lymphocytic leukaemia), Richter's syndrome , AML/secondary AML, ALL , High-
risk myelodysplastic syndrome (MDS), CMML (chronic myelomonocytic leukemia)
Eastern Cooperative Oncology Group (ECOG) performance status of 2
Must have received at least 2 prior lines of therapy
Documented active disease requiring treatment per respective NCCN/ESMO guideline that is relapsed or refractory defined as: Recurrence of disease after response to prior line(s) of therapy Or progressive disease after completion of the treatment regimen preceding entry into the study
Adequate hematologic, hepatic and renal function
Women should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test before start of dosing if of child-bearing potential or must have evidence of nonchildbearing potential
Men should be willing to use barrier contraception (ie, condoms) and refrain from sperm donation during and after the conduct of the trial

Exclusion Criteria

Treatment with any of the following: any other chemotherapy, immunotherapy or anticancer agents within 2 weeks, any hematopoietic growth factors (e.g., filgrastim; [G-CSF] or sargramostin [GM-CSF]) within 7 days of the first dose of investigational product or pegylated G-CSF (pegfilgrastim) or darbepoetin within 14 days, any full-dose level anti-coagulation treatment sufficiently prior to treatment that INR is <1.5 (DVT/PE prophylaxis dose is allowed) or Major surgery (excluding placement of vascular access) within 4 weeks (with regard to the first dose of study treatment on this protocol)
With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment
Presence of, or history of, CNS lymphoma, leptomeningeal disease or spinal cord compression
History of prior nonhematologic malignancy with exceptions mentioned in protocol
Undergone any procedures or experienced any of the conditions listed in protocol exclusion criteria currently or in the preceding 6 months
Patients with any of the following: evidence of severe or uncontrolled systemic disease, asecretory myeloma, a known history of infection with human immunodeficiency virus (HIV), serological evidence of active Hepatitis B infection, cardiac abnormalities as mentioned in the protocol, previous allogeneic bone marrow transplant, adrenal gland insufficiency or pancreatitis
History of severe allergic or anaphylactic reactions to BH3 mimetics or history of hypersensitivity to active or inactive excipients of AZD4573
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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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