NL-OMON50684CompletedNot Applicable
A Phase 1, Open-Label, Multicentre, Non-Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD4573, a Potent and Selective CDK9 Inhibitor, in Subjects with Relapsed or Refractory Haematological Malignancies - AZD4573
Astra Zeneca0 sites13 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •1. Provision of signed and dated, written informed consent prior to any
- •study-specific procedures, sampling and analyses.
- •2. Men and women >=18 years of age
- •3. Patients with histologically confirmed, relapsed or refractory
- •haematological malignancies, with at least one measurable lesion >= 1.5 cm and
- •where in the opinion of the Investigator, a clinical trial is the best option
- •for next treatment based on prior response and/or tolerability to standard of
- •care, e.g., but not limited to:
- •o B-cell Non-Hodgkin lymphoma
- •o T-cell Non-Hodgkin lymphoma
- •o Small lymphocytic lymphoma (SLL)
- •o Multiple myeloma (MM) , Arm B:
- •o CLL (chronic lymphocytic leukaemia)
- •o Richter*s syndrome
- •o AML/secondary AML
- •o High-risk myelodysplastic syndrome (MDS) (according to revised International
- •prognostic scoring system IPSS- R)
- •o CMML (chronic myelomonocytic leukaemia),
- •NOTE: AML/ALL patients must have pathologically confirmed first or second
- •relapsed or primary refractory AML using the World Health Organization (WHO)
- •definition or European LeukemiaNet (ELN) recommendations. A bone marrow blast
- •count of >5% will be sufficient in the appropriate setting of a patient with a
- •prior diagnosis of AML/ALL.
- •NOTE: AML patients with APL (acute promyelocytic leukaemia FAB subtype M3) will
- •be excluded
- •NOTE: Patients >70 years of age with untreated AML who are considered unfit for
- •intensive treatment or who refuse intensive treatment, may be considered
- •eligible for the study, upon consultation and agreement between the Sponsor and
- •the Investigator.
- •NOTE: Patients with DLBCL subtypes such as Richter's syndrome, Transformed
- •Follicular Lymphoma, Primary Mediastinal Lymphoma and High-grade lymphomas
- •[e.g. double-hit]) are also eligible to be included in the Cohort 2A DLBCL
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
- •5. Must have received at least 2 prior lines of therapy for the treatment of
- •current histology and a clinical trial is best option for next treatment based
- •on prior response and/or tolerability to standard of care. Refer to National
- •Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology
- •(ESMO) guidelines of each respective histology for guidance. NOTE: For some
- •disease indications, for example Richter*s syndrome, failure of one therapy
- •(e.g., R-CHOP) would be sufficient to consider a patient for enrolment in a
- •study with an Investigational agent. Disease indications, where there may be no
- •standard of care or standard of care options have been exhausted after failure
- •of first line therapy, these patients may be discussed and considered by
- •Sponsor and Investigator on a case by case basis for enrolment into the study
- •and decisions to enrol such patients documented in writing.
- •6. Documented active disease requiring treatment per respective NCCN/ESMO
- •guideline that is relapsed or refractory defined as:
- •o Recurrence of disease after response to prior line(s) of therapy
- •o or progressive disease after completion of the treatment regimen preceding
- •entry into the study
- +4 more not shown
Exclusion Criteria
- •1. Treatment with any of the following:
- •o Any other chemotherapy, immunotherapy or anticancer agents, including
- •investigational agents, within 2 weeks of the first dose of study treatment
- •o Any haematopoietic growth factors (e.g., filgrastim [granulocyte
- •colony-stimulating factor; G-CSF], sargramostin [granulocyte-macrophage
- •colony-stimulating factor; GM-CSF]) within 7 days of the first dose of study
- •drug or pegylated G-CSF (pegfilgrastim) or darbepoetin within 14 days of the
- •first dose of study drug
- •o Major surgery (excluding placement of vascular access) within 4 weeks of the
- •first dose of study treatment
- •Any full-dose level anti-coagulation treatment sufficiently prior to treatment
- •that INR is <1.5 (DVT/PE prophylaxis dose is allowed)
- •2. Patients with asecetory mylema
- •3. With the exception of alopecia, any unresolved toxicities from prior therapy
- •greater than CTCAE Grade 1 at the time of starting study treatment.
- •4. Presence of, or history of, central nervous system (CNS) lymphoma,
- •leptomeningeal disease or spinal cord compression.
- •5. History of prior nonhaematologic malignancy except for the following:
- •o Malignancy treated with curative intent and with no evidence of active
- •disease present for more than 2 years before screening and felt to be at low
- •risk for recurrence by treating physician.
- •o Adequately treated lentigo maligna melanoma without current evidence of
- •disease or adequately controlled nonmelanomatous skin cancer.
- •o Adequately treated carcinoma in situ without current evidence of disease.
- •6. As judged by the Investigator, any evidence of severe or uncontrolled
- •systemic disease (e.g., severe hepatic impairment, interstitial lung disease
- •[bilateral, diffuse, parenchymal lung disease]), or current unstable or
- •uncompensated respiratory or cardiac conditions, or uncontrolled hypertension,
- •history of, or active, bleeding diatheses (e.g., hemophilia or von Willebrand
- •disease) or uncontrolled active systemic fungal, bacterial, viral, or other
- •infection (defined as exhibiting ongoing signs/symptoms related to the
- •infection and without improvement, despite appropriate antibiotics or other
- •treatment), or intravenous anti-infective treatment within 2 weeks before first
- •dose of study drug.
- •7. Known history of infection with human immunodeficiency virus (HIV).
- •8. Serological evidence of active Hepatitis B infection
- •9. Undergone any of the following procedures or experienced any of the
- •following conditions currently or in the preceding 6 months:
- •o coronary artery bypass graft
- •o angioplasty
- •o vascular stent - for the purposes of clarification, a patient who has had a
- •cardiac stent or arterial stent currently or in the preceding 6 months will not
- •be eligible for the study. However, a patient who has had a venous stent to
- •prevent life-threatening conditions, currently or in the preceding 6 months,
- •will be eligible for the study.
- •o myocardial infarction
- •o angina pectoris
- •o congestive heart failure (New York Heart Association Class >=2)
- •o ventricular arrhythmias requiring continuous therapy
- •o atrial fibrillation, which is uncontrolled
- +4 more not shown
Investigators
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