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Study of M4344 in Combination With Niraparib

NCT04655183 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-06-30

No results posted yet for this study

Summary

Study will include 3 parts. Aim of Part 1 of this study is to establish the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) for M4344 (is an Ataxia Telangiectasia Mutated and Rad3-related \[ATR\] inhibitors) in combination with niraparib in participants with advanced solid tumors. Aim of Parts 2 and 3 of the study is to provide clinical proof-of-concept for the preclinically predicted synergistic efficacy of ATR and poly(ADP-Ribose) polymerase (PARP) inhibitors (PARPi) in defined populations of participants with advanced breast cancer (aBC) with DDR mutations with an unmet medical need.

Conditions

Interventions

DRUG

Niraparib

Niraparib will be administered orally, once daily.

DRUG

M4344

M4344 will be administered once daily or on an intermittent schedule in combination with niraparib.

DRUG

Niraparib

Niraparib will be administered orally once daily at the RDE as determined in Part 1 of this study.

DRUG

M4344

M4344 will be administered at a dose and schedule that was determined as RDE in Part 1A in combination with niraparib.

DRUG

Niraparib

Niraparib will be administered orally, once daily. Dose of niraparib will be escalated beyond the dose in Part 1A.

DRUG

Niraparib

Niraparib will be administered as single agent at the approved dose.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

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Diseases

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 NCT04655183 on ClinicalTrials.gov