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

NCT03797261 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-12-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Venetoclax

tablet, oral

DRUG

AMG 176

solution, intravenous

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03797261 on ClinicalTrials.gov