Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
Lead Sponsor:
Suzhou Kintor Pharmaceutical Inc,
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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 inc...
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 cont...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04103853
Start Date
September 6 2017
End Date
June 30 2020
Last Update
September 24 2021
Active Locations (7)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
2
Sun-Yat-sen University Cancer center
Guangzhou, Fujian, China
3
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
4
Hunan Cancer Hospital
Changsha, Hunan, China