Pevonedistat, Azacitidine (or Decitabine), and Venetoclax for the Treatment of Patients With Acute Myelogenous Leukemia

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Medical College of Wisconsin
Study ID
NCT04172844
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Myelogenous Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    75mg/m\^2 Days 1-7 given IV
  • Venetoclax — DRUG
    100 mg on cycle 1 day 1, 200 mg daily on cycle 1 day 2, 400 mg on cycle 1 day 3 and thereafter from cycle 1. Venetoclax is given for a minimum of 21 days and a maximum of 28 days. Administered orally.
  • Pevonedistat — DRUG
    The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.

Study Details

This is a phase Ib study with a 3 + 3 dose escalation design followed by a dose-expansion phase.

Key Dates

Start date
Jan 13, 2020
Status verified
May 2024
Primary completion
Dec 12, 2021
Completion
Feb 27, 2022

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pevonedistat Dose Escalation
    This study uses a varied 3 + 3 design. Three patients will be started at a dose of 10 mg/m\^2 days 1, 3 and 5. If no DLTs are observed in the first 3 participants, then a new cohort will be enrolled at the next planned dose level of 15 mg/m\^2 days 1, 3 and 5. If two out of three subjects experience a DLT, then they will de-escalate one dose level. If one subject in three experiences a DLT, then expand up to three subjects at 20 mg/m\^2 day 1, 3 and 5. If two out of six subjects experience a DLT, de-escalate one level. All subjects will receive Azacitidine and Venetoclax at the indicated dosages and timing.
  • Experimental: Dose Expansion Phase
    Patients will receive the recommended phase 2 dose (RP2D) identified from dose-escalation phase.

Primary Outcome Measure

Recommended phase 2 dose of pevonedistat when co-administered with azacitidine and venetoclax in patients with AML. [ Time Frame: Up to 28 days (one cycle) for each dosing cohort. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNFroedtert Hospital and the Medical College of Wisconsin· Milwaukee, WI

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