NCT03218683

Study of AZD5991 Alone or in Combination With Venetoclax in Relapsed or Refractory Haematologic Malignancies.

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Relapsed or Refractory Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	AZD5991	AZD5991 will be administered intravenously for 9 cycles (each cycle 21 days) or until patient derives treatment benefit or progresses
DRUG	AZD5991 + Venetoclax	Ascending oral doses of AZD5991 and/or venetoclax until no longer tolerated or disease progression

Timeline

• Start date: 2017-08-02
• Primary completion: 2021-10-08
• Completion: 2021-10-08
• First posted: 2017-07-14
• Last updated: 2022-09-23

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study