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Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer

NCT04103853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-09-24

No results posted yet for this study

Summary

This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer.

This study includes two stages, stage I: single- and multiple-dose tolerance and pharmacokinetic study; stage 2: preliminary efficacy and safety study.

Conditions

Interventions

DRUG

Proxalutamide

Stage1:Dose esclation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Tianjin Medical University Cancer Institute and Hospital

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Hunan Cancer Hospital

    collaborator OTHER

  • Suzhou Kintor Pharmaceutical Inc,

    lead INDUSTRY

Principal Investigators

  • Ke Chen · Suzhou Kintor Pharmaceuticals,inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2019-05-22
Completion
2020-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04103853 on ClinicalTrials.gov