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Phase 2 Study of KHK2375 in Subjects With Advanced or Recurrent Breast Cancer

NCT03291886 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2022-06-21

No results posted yet for this study

Summary

The primary objective of this study is to investigate the effect of 5 mg KHK2375 on progression free survival (PFS) when administered orally at weekly intervals in combination with exemestane in a placebo-controlled, double-blind comparative study in subjects with advanced or recurrent hormone receptor-positive breast cancer. The secondary objectives are to investigate the effect of on overall survival (OS) and the antitumor effect and to evaluate the pharmacokinetics and safety.

Conditions

  • Advanced or Recurrent Breast Cancer

Interventions

DRUG

Entinostat

Given PO

DRUG

Entinostat(Placebo)

Given PO

DRUG

Exemestane

Given PO

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2019-04-04
Completion
2021-03-26

Countries

  • Japan

Study Locations

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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 NCT03291886 on ClinicalTrials.gov