A Study of Venetoclax and AMG 176 in Patients With Relapsed/Refractory Hematologic Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT03797261
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    tablet, oral
  • AMG 176 — DRUG
    solution, intravenous

Study Details

This dose-escalation study evaluating the safety, pharmacokinetics and preliminary efficacy of venetoclax in combination with AMG 176 in participants with relapsed or refractory acute myeloid leukemia (AML) and participants with Non-Hodgkin's lymphoma (NHL)/diffuse large B-cell lymphoma (DLBCL). This study will include a dose escalation phase to identify the maximum tolerated dose/recommended phase 2 dose (MTD/RPTD) of venetoclax plus AMG 176 as well as a dose expansion phase to confirm safety, explore efficacy, and confirm the suitability of the preliminary RPTD.

Key Dates

Start date
Mar 18, 2019
Status verified
Dec 2021
Primary completion
Dec 30, 2019
Completion
Dec 30, 2019

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax + AMG 176
    Venetoclax and AMG 176 will be administered in combination. Different combinations of dose levels for venetoclax and AMG 176 will be explored.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RPTD) for Venetoclax + AMG 176 [ Time Frame: Up to 28 days after first dose of study drug in a dose-escalation phase ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope /ID# 207393DuarteCalifornia91010-
USC Norris Cancer Center /ID# 207396Los AngelesCalifornia90033-
University of Iowa Hospitals and Clinics /ID# 207459Iowa CityIowa52242-
Univ Kansas Med Ctr /ID# 207480Kansas CityKansas66160-
Duplicate_Dana-Farber Cancer Institute /ID# 207367BostonMassachusetts02215-
Washington University-School of Medicine /ID# 206995St LouisMissouri63110-
NYU Langone Medical Center /ID# 207390New YorkNew York10016-6402-
Unc /Id# 207388Chapel HillNorth Carolina27599-
UPMC Hillman Cancer Ctr /ID# 208482PittsburghPennsylvania15232-

Find similar trials in Duarte, CA

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By research site
City of Hope· Duarte, CAUSC Norris Cancer Center· Los Angeles, CAUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniv Kansas Med Ctr· Kansas City, KSDuplicate_Dana-Farber Cancer Institute· Boston, MAWashington University-School of Medicine· St Louis, MO

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