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

Part of paid clinical trials in Orange, California.

Sponsor
AstraZeneca
Study ID
NCT03218683
Phase
PHASE1
Status
Terminated

Conditions

  • Relapsed or Refractory Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 2, 2017
Status verified
Sep 2022
Primary completion
Oct 8, 2021
Completion
Oct 8, 2021

Study Design

Enrollment
70 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy AZD5991
    Dose escalation - multiple dose levels
  • Experimental: Monotherapy AZD5991 expansion
    Dose expansion
  • Experimental: AZD5991 + venetoclax
    Dose escalation - multiple dose levels

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: At every treatment and follow up visit until disease progression. Expected to be for up to 12 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
Research SiteOrangeCalifornia92868-
Research SiteAuroraColorado80045-
Research SiteAtlantaGeorgia30322-
Research SiteBostonMassachusetts02215-
Research SiteSt LouisMissouri63110-
Research SiteNew YorkNew York10065-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97239-
Research SiteNashvilleTennessee37203-
Research SiteHoustonTexas77030-

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