Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies.

Status: Active

Description

This study is a multicenter, open-label, nonrandomized, sequential group, dose-escalation study to assess safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ascending doses of AZD5991 in subjects with relapsed or refractory hematologic malignancies.

Eligibility Criteria

Inclusion Criteria

  • Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
  • Men and women 18 to 85 years of age, inclusive.
  • Diagnosis of any of the following hematologic malignancies:
  • non-Hodgkin lymphoma
  • Richter syndrome
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma (SLL)
  • T-cell lymphoma
  • multiple myeloma (MM)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
  • Must have received at least 2 prior lines of therapy for the treatment of current histology; there are no treatment options available known to provide clinical benefit. Refer to National Comprehensive Cancer Network (NCCN) guidelines of each respective histology for guidance.
  • 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 investigational agents from a previous clinical study within 4 half-lives of said prior investigational agent(s) with regard to the first dose of study treatment on this protocol.
  • Any other chemotherapy, immunotherapy or anticancer agents within 2 weeks of the first dose of study treatment.
  • Any hematopoietic growth factors (eg, 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.
  • Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
  • Except for alopecia, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
  • Presence of, or history of, central nervous system (CNS) lymphoma, leptomeningeal disease or spinal cord compression.
  • As judged by the Investigator, any evidence of severe or uncontrolled systemic disease (eg, 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 (eg, 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.

Locations & Contacts

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
AstraZeneca Pharmaceuticals LP

Trial IDs

Primary ID D6910C00001
Secondary IDs NCI-2017-01390
Clinicaltrials.gov ID NCT03218683