NCT03218683: Phase 1/2: Study of AZD5991 Alone or with Venetoclax in Relapsed Hem Malignancies

NCT03218683: Phase 1/2: Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.

Study of AZD5991 Alone or in Combination With Venetoclax in 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 Part 1 of the study is monotherapy dose escalation. Closed November 2020 Part 2 of the study is monotherapy expansion groups for relapsed/refractory chronic lymphocytic leukaemia (CLL), AML/ myelodysplastic syndromes (MDS), and multiple myeloma (MM). Closed November 2020 Part 3 is a sequential, dose-escalation study of the combination of AZD5991 and venetoclax in subjects with relapsed/refractory AML

Sponsor

AstraZeneca

Multiple Locations

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ClinicalTrials.gov Identifier: NCT03218683

Official Title: A Phase 1/1b/2a, 3-Part, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD5991 Monotherapy and in Combination With Venetoclax in Subjects With Relapsed or Refractory Haematologic Malignancies

First Posted: July 14, 2017

Click here for details on ClinicalTrials.gov

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Drug: AZD5991

Drug: AZD5991 + Venetoclax

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Mcl-1 Inhibitor AZD5991 (Code C137989)

Mcl-1 Inhibitor AZD5991

AZD-5991

AZD5991

Mcl-1 Inhibitor AZD5991

MCL1 Inhibitor AZD5991

Venetoclax (Code C103147)

4-(4-((2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide

ABT-0199

ABT-199

ABT199

GDC-0199

RG7601

Venclexta

Venclyxto

Venetoclax

VENETOCLAX

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Nat Commun; 2018 Dec

Discovery of Mcl-1-specific inhibitor AZD5991 and preclinical activity in multiple myeloma and acute myeloid leukemia

https://pubmed.ncbi.nlm.nih.gov/30559424/

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Locations

United States, California

United States, Colorado

United States, Georgia

United States, Massachusetts

United States, Missouri

United States, New York

United States, Ohio

United States, Oregon

United States, Tennessee

United States, Texas