CompletedNCT04103853Updated Sep 24, 2021

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

A Phase 1 interventional study of Proxalutamide in Metastatic Breast Cancer, sponsored by Suzhou Kintor Pharmaceutical Inc,. Completed at 7 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by Suzhou Kintor Pharmaceutical Inc, · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 2 years after the study started (first participant enrolled Sep 2017, registered Sep 2019).

Phase: Phase 1
Study type: Interventional
Enrollment: 63
Allocation: Not applicable
Ages: 18 Years and older
Sex: Female

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.

Read the detailed description

This study is a multi-center, open-label, dose-esclation study.

Subjects will be enrolled to the 100mg, 200mg, 300mg, 400mg and 500mg group in turn. Unless DLT was found, the dose esclation will continue. 28 days of DLT observation period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent.

After the completion of stage 1, 2 doses for the stage 2 will be determined. In stage 2, patients with AR-positive metastatic breast cancer will be selected to explore the efficacy and safety of proxalutamide, and biomarkers will be explored.

Conditions studied

Metastatic Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

AR-positive metastatic breast cancer
Proxalutamide
metastatic breast cancer
GT0918

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 63 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Suzhou Kintor Pharmaceutical Inc, is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Inclusion criteria

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；

Exclusion criteria

Exclusion Criteria:

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;

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 63 participants (actual)

Study arms

Experimental
Proxalutamide
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

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

What researchers measure

Primary outcomes

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.
Time frame: 35 days
maximum tolerated dose (MTD)
100 mg, 200 mg, 300 mg, 400 mg or 500 mg of GT0918
Time frame: 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.
Time frame: 16 weeks

Secondary outcomes

maximum concentration (Cmax)
Pharmacokinetics
Time frame: 35 days
time that maximum concentration is observed (tmax)
Pharmacokinetics
Time frame: 35 days
area under the concentration time-curve from time zero to infinity (AUC0∞)
Pharmacokinetics
Time frame: 35 days
terminal elimination half life (t½)
Pharmacokinetics
Time frame: 35 days
drug clearance (CL)
Pharmacokinetics
Time frame: 35 days
apparent volume of distribution (Vd)
Pharmacokinetics
Time frame: 35 days
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
200 mg, 300 mg of GT0918
Time frame: 16 weeks

Study locations

7 sites

Beijing Cancer Hospital
Beijing, Beijing 100142, China
Sun-Yat-sen University Cancer center
Guangzhou, Fujian, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China

References and documents

Publications

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. PubMed 36182805 ↗
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. PubMed 34392453 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04103853
Lead sponsor: Suzhou Kintor Pharmaceutical Inc,
Collaborators: Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Sun Yat-sen University, Ruijin Hospital, The First Affiliated Hospital with Nanjing Medical University, Hebei Medical University Fourth Hospital, Hunan Cancer Hospital
Responsible party: Sponsor
First posted: Sep 26, 2019
Start date: Sep 6, 2017
Primary completion: May 22, 2019
Completion: Jun 30, 2020
Last update: Sep 24, 2021

Study contacts

Ke Chen

study director · Suzhou Kintor Pharmaceuticals,inc

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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