NCT04103853

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2017

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

September 20, 2019

Last Update Submit

September 22, 2021

Conditions

Metastatic Breast Cancer

Keywords

AR-positive metastatic breast cancerProxalutamidemetastatic breast cancerGT0918

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting Toxicity(DLT)

    Each dose cohort will initially include 3 evaluable patients for assessment of toxicity within the 35 days following the first dose of GT0918.

    35 days

  • maximum tolerated dose (MTD)

    100 mg, 200 mg, 300 mg, 400 mg or 500 mg of GT0918

    35 days

  • Disease Control Rate(DCR)

    Preliminary evaluation of the DCR of GT0918 tablets in AR positive metastatic breast cancer patients, and determination of the recommended dose of proclamine in clinical trials.

    16 weeks

Secondary Outcomes (7)

  • maximum concentration (Cmax)

    35 days

  • time that maximum concentration is observed (tmax)

    35 days

  • area under the concentration time-curve from time zero to infinity (AUC0∞)

    35 days

  • terminal elimination half life (t½)

    35 days

  • drug clearance (CL)

    35 days

  • +2 more secondary outcomes

Study Arms (1)

Proxalutamide

EXPERIMENTAL

Stage one - Dose climbing: Each dose cohort will assess toxicity within the 35 days following the first dose of GT0918. Stage two- the expansion cohort : 30 patients will be enrolled to the 200mg cohort . 15 patients will be enrolled to the 300mg cohort.

Drug: Proxalutamide

Interventions

ProxalutamideDRUG

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

Proxalutamide

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years female;
  • Stage 1:Histology or cytology confirmed metastatic breast cancer, first-line chemotherapy or targeted therapy failure or intolerance
  • Stage 2: Histological or cytological confirmed metastatic breast cancer patients who failed or intolerant to anti-tumor therapy; have a positive AR test result;
  • At least one measurable lesion based on RECIST version 1.1 ;
  • ECOG performance status: 0-1;
  • Have a predicted life expectancy of greater than 3 months;
  • The functions of the important organs are confirmed with the following requirement:
  • Hemoglobin (HGB) ≥ 90 g/L(no blood transfusion within 14 days );
  • Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L；
  • Platelets (PLT) ≥ 100×10\^9/L(If the coagulation function is normal,Platelets (PLT) ≥ 75×10\^9/L )；
  • Total bilirubin (TBIL) ≤ 1.5× Upper limit of normal value (ULN) -Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine -
  • Aminotransferase (ALT) ≤2.5× ULN
  • Understand and voluntarily sign the informed consent form；
  • Subject is willing and able to comply with all protocol required visits and assessments；

You may not qualify if:

  • Pregnant, lactating women, or those who have fertility and are reluctant to take effective contraceptive measures;
  • Prior chemotherapy, radiation, targeted therapy ,androgen receptor inhibitors therapy (abiraterone,enzalutamide,etc )，other endocrine therapy ，and has acceptted traditional chinese herbal medicine treatment less than 4 weeks prior to the start of study medication.
  • Has severe cardiovascular disease
  • The toxicity of the previous treatment plan has not been restored before enrollment, and there is still non-hematologic toxicity of grade 1 or above (except for hair loss)
  • Known gastrointestinal disease or condition that affects the absorption of GT0918;
  • Known or suspected brain metastases, including the central nervous system and spinal cord compression or meningeal metastasis;
  • History of severe central nervous system diseases (including patients with epilepsy);
  • Known hypersensitivity to proxalutmide or its excipients.
  • Participated in clinical trials of other drugs or medical devices within one month prior to screening, or plan to participate in any other clinical trials during the study period;
  • Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Sun-Yat-sen University Cancer center

Guangzhou, Fujian, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (2)

  • Jiang H, Ouyang Q, Yin Y, Tong Z, Shen K, Yuan Z, Geng C, Liu Y, Song G, Ran R, Li W, Qu Q, Wang M, Meng L, Tong Y, Li H. Proxalutamide in patients with AR-positive metastatic breast cancer: Results from an open-label multicentre phase Ib study and biomarker analysis. Eur J Cancer. 2022 Nov;176:1-12. doi: 10.1016/j.ejca.2022.08.025. Epub 2022 Sep 28.

    PMID: 36182805DERIVED

  • Li H, Song G, Zhou Q, Ran R, Jiang H, Zhang R, Liu Y, Zhang J, Meng L, Ma L, Sun Y, Wang M, Zhou Q, Yan H, Zhou Q, Dong X, Tong Y. Activity of preclinical and phase I clinical trial of a novel androgen receptor antagonist GT0918 in metastatic breast cancer. Breast Cancer Res Treat. 2021 Oct;189(3):725-736. doi: 10.1007/s10549-021-06345-x. Epub 2021 Aug 14.

    PMID: 34392453DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

proxalutamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ke Chen

    Suzhou Kintor Pharmaceuticals,inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 26, 2019

Study Start

September 6, 2017

Primary Completion

May 22, 2019

Study Completion

June 30, 2020

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)