Back to resultsA Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
Primary Purpose
ER+ / HER2- Advanced Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR6390、Famitinib
Sponsored by
About this trial
This is an interventional treatment trial for ER+ / HER2- Advanced Breast Cancer
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；
- Pregnant or breast-feeding women;
- Central nervous system (CNS) invasion.
Sites / Locations
- Harbin Medical University Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR6390+famitinib
Arm Description
Participants will receive SHR6390 in combination with famitinib.
Outcomes
Primary Outcome Measures
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
Secondary Outcome Measures
AEs+SAEs
from the first drug administration to within 30 days for the last treatment dose
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac
Objective Response Rate (ORR)
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Full Information
NCT ID
NCT05103826
First Posted
October 21, 2021
Last Updated
August 13, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05103826
Brief Title
A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor R & D Strategy Adjustment
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ER+ / HER2- Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR6390+famitinib
Arm Type
Experimental
Arm Description
Participants will receive SHR6390 in combination with famitinib.
Intervention Type
Drug
Intervention Name(s)
SHR6390、Famitinib
Intervention Description
SHR6390, oral;Famitinib, oral.
Primary Outcome Measure Information:
Title
(Safety Lead-in) dose limited toxicity (DLT) of SHR6390+famitinib in the first cycle
Time Frame
up to 28 days
Title
(Safety Lead-in) Recommended Phase II Dose (RP2D) of SHR6390+famitinib
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
AEs+SAEs
Description
from the first drug administration to within 30 days for the last treatment dose
Time Frame
up to 24 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Cmax
Time Frame
6 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Tmax
Time Frame
6 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: t1/2
Time Frame
6 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: AUC
Time Frame
6 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: CL/F
Time Frame
6 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Vz/F
Time Frame
6 months
Title
Evaluation of pharmacokinetic parameter of SHR6390+famitinib: Rac
Time Frame
6 months
Title
Objective Response Rate (ORR)
Description
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
Title
Disease control rate (DCR)
Description
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Time Frame
up to 24 months
Title
Duration of response (DoR)
Description
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Time Frame
up to 24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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；
Pregnant or breast-feeding women;
Central nervous system (CNS) invasion.
Facility Information:
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of SHR6390 Combined With Famitinib in the Treatment of ER + / HER2- Advanced Breast Cancer
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