Back to resultsSHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
Primary Purpose
ER+ HER2- Advanced Breast Cancer
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR9549
Sponsored by
About this trial
This is an interventional treatment trial for ER+ HER2- Advanced Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Aged 18-70 years.
- Confirmation of ER positive; HER2 negative Advanced breast cancer
- Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
- Receipt of ≤2 lines of prior chemotherapy for advanced disease.
- Any menopausal status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.
Exclusion Criteria:
- Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
- Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
- uncontrolled central nervous system metastatic disease.
- Any evidence of severe or uncontrolled systemic diseases.
- Inadequate bone marrow reserve or organ function.
Sites / Locations
- The 307th Hospital of Military Chinese People's Liberation Army
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR9549 dose escalation and expansion(s)
Arm Description
Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients
Outcomes
Primary Outcome Measures
Dose Limited Toxicity (DLT)
to determine DLT in order to assess the tolerability of SHR9549
Maximum Tolerated Dose (MTD)
to determine MTD in order to assess the tolerability of SHR9549
Secondary Outcome Measures
Peak Plasma Concentration (Cmax)
Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
Area under the plasma concentration versus time curve (AUC)
Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
overall response rate (ORR)
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
progression free survival (PFS)
Antitumour activity evaluation by following up patients' progression and survival
Incidence of Treatment-Emergent Adverse Events
to assess the safety of SHR9549
Full Information
NCT ID
NCT03596658
First Posted
June 25, 2018
Last Updated
August 29, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03596658
Brief Title
SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
Official Title
Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women With ER Positive HER2 Negative Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Sponsor R & D Strategy Adjustment
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
October 14, 2019 (Actual)
Study Completion Date
October 14, 2019 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.
Detailed Description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative 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
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR9549 dose escalation and expansion(s)
Arm Type
Experimental
Arm Description
Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients
Intervention Type
Drug
Intervention Name(s)
SHR9549
Other Intervention Name(s)
SHR9549 tablet
Intervention Description
If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
Primary Outcome Measure Information:
Title
Dose Limited Toxicity (DLT)
Description
to determine DLT in order to assess the tolerability of SHR9549
Time Frame
baseline through 28 days
Title
Maximum Tolerated Dose (MTD)
Description
to determine MTD in order to assess the tolerability of SHR9549
Time Frame
baseline through 28 days
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
Time Frame
baseline through 12 weeks
Title
Area under the plasma concentration versus time curve (AUC)
Description
Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
Time Frame
baseline through 12 weeks
Title
overall response rate (ORR)
Description
Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Time Frame
every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
Title
progression free survival (PFS)
Description
Antitumour activity evaluation by following up patients' progression and survival
Time Frame
every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
Title
Incidence of Treatment-Emergent Adverse Events
Description
to assess the safety of SHR9549
Time Frame
baseline through 30 days after study completion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-70 years.
Confirmation of ER positive; HER2 negative Advanced breast cancer
Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
Receipt of ≤2 lines of prior chemotherapy for advanced disease.
Any menopausal status.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.
Exclusion Criteria:
Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
uncontrolled central nervous system metastatic disease.
Any evidence of severe or uncontrolled systemic diseases.
Inadequate bone marrow reserve or organ function.
Facility Information:
Facility Name
The 307th Hospital of Military Chinese People's Liberation Army
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
12. IPD Sharing Statement
Learn more about this trial
SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
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