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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
SHR6390, oral;Famitinib, oral.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
Time frame: up to 28 days
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
Time frame: up to 28 days
AEs+SAEs
from the first drug administration to within 30 days for the last treatment dose
Time frame: up to 24 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F
Time frame: 6 months
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac
Time frame: 6 months
Objective Response Rate (ORR)
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Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Time frame: up to 24 months
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Time frame: up to 24 months
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Time frame: up to 24 months