Study of AZD5991 in Relapsed or Refractory Haematologic Malignancies.



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Lymphoma, Lymphoma, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 85
Updated:1/23/2019
Start Date:August 2, 2017
End Date:October 23, 2019
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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A Phase 1, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 in Subjects With Relapsed or Refractory Haematologic Malignancies

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.


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.
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