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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

Clinical Trial Details

This clinical trial is for men and women with non-Hodgkin lymphoma, Richter's syndrome, chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL), T-cell lymphoma, multiple myeloma (MM), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS). The goal of therapy for these diseases is to induce tumor regression or delay the progression of disease in order to improve overall outcome. Patients who require treatment are frequently treated with chemotherapeutic and/or immunotherapeutic treatment options. However, due to the frequent development of progressive resistance to treatment in these disease types, novel mechanisms of action are needed to offer additional treatment options to patients who have experienced disease progression and for whom no standard of care exists. 

BH3 mimetics are a class of molecules that disrupt interactions between specific cancer cells, with particularly broad activity in hematologic malignancies. AZD5991 is an innovative, BH3 mimetic that was specifically designed to disrupt MCL-1 protein complexes while sparing BCL-2 and BCL-XL protein complexes. Similar preclinical results observed with another MCL-1 inhibitor provide support of the findings with AZD5991. This first in human phase 1 study is designed to investigate the safety and tolerability of AZD5991. 
    
Subjects will be assigned to a dose level cohort that will consist of an initial starting dose, followed by a higher dose for subsequent administrations. AZD5991 will be administered by IV infusion weekly for up to 9 cycles (approximately 8.5 months). Subjects who continue to derive benefit from AZD5991 after 9 cycles of treatment may be able to continue this treatment. Following the discontinuation of therapy, subjects will be followed for disease progression (if therapy discontinued for other reasons), and for alternate therapy.

Key Eligibility: 

   • Men and women between the ages of 18 and 85 
   • Diagnosis of non-Hodgkin lymphoma (NHL), Richter's syndrome, chronic lymphocytic leukemia (CLL), T-cell lymphoma, multiple myeloma (MM), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) that is relapsed/refractory after at least two lines of therapy, and no standard of care exists. 
   • Must have failed to achieve a response or have recurrent disease after previous treatment 
   • Detailed eligibility reviewed when you contact the study team 

Contact

Amelyn Rodriguez
amr2017@med.cornell.edu
212-746-1362

Primary Investigator

Richard Furman MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1706018322

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

1