A Phase I Study to Evaluate Safety 、Tolerability 、 Pharmacokinetics and Efficacy of SHR6390 in Combination With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country3 target enrollmentOctober 25, 2021

ConditionsER+ / HER2- Advanced Breast Cancer

InterventionsSHR6390、Famitinib

DrugsSHR6390、Famitinib

Overview

Phase: Phase 1
Intervention: SHR6390、Famitinib
Conditions: ER+ / HER2- Advanced Breast Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 3
Locations: 1
Primary Endpoint: (Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to assess the safety 、tolerability 、 pharmacokinetics and efficacy of SHR6390 combined with famitinib in the treatment of ER + / HER2- advanced breast cancer.

Registry

clinicaltrials.gov

Start Date

October 25, 2021

End Date

June 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female subjects aged 18 to 75 years old；
•ECOG performance status 0-1;
•Life expectancy is not less than 12 weeks;
•Histological or cytological confirmation of ER+/HER2- recurrent/metastatic breast cancer;
•Participants with measurable disease must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST1.1;
•Adequate function of major organs;
•Voluntary participation in the study, signed informed consent, good compliance and willingness to cooperate with follow-up.

Exclusion Criteria

•Confirmed diagnosis of HER2 positive disease;
•Participants who previously received SHR6390 or VEGFR inhibitors;
•Allergy to study drug or its components;
•Participated in other drug clinical trials within 4 weeks before the first dose;
•Other malignancies within 3 years, except cured non-melanoma skin cancer , skin basal cell carcinoma and squamous-cell carcinoma or carcinoma in situ of the cervix;
•Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class \> 2), or ventricular arrhythmia which need medical intervention；
•Tumor has invaded important blood vessels or the tumor is likely to invade important blood vessels and cause fatal hemorrhage during treatment;
•Urine routine test indicates urine protein ≥(++), or 24-hour urine protein \>1.0g;
•Active HBV/HCV/HIV infection;
•The investigators determined that other conditions were inappropriate for participation in this clinical trial；