Back to resultsEvaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Primary Purpose
Breast Cancer
Status
Active
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Amcenestrant (SAR439859)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion criteria :
- Participants must be postmenopausal women.
- Breast adenocarcinoma patients with locally advanced not amenable to radiation or surgery, inoperable and/or metastatic disease.
- Either the primary or any metastatic site must be positive for estrogen receptor (ER) (>1% staining by immunohistochemistry).
- Either the primary tumor or any metastatic site must be human epidermal growth factor receptor 2 non-overexpressing.
- Patients with at least 6 months of prior endocrine therapy.
Exclusion criteria:
- Eastern Cooperative Oncology Group Performance Status (ECOG) ≥2.
- Significant concomitant illness that would adversely affect participation in the study.
- Patients with a life expectancy less than 3 months.
- Patient not suitable for participation, whatever the reason.
- Major surgery within 4 weeks prior to first study treatment administration.
- Treatment with strong and moderate cytochrome P450 3A inhibitors/inducers.
- Patients with known endometrial disorders, uterine bleeding or ovarian cysts.
- Treatment with anticancer less than 2 weeks before first study treatment.
- Prior treatment with selective estrogen receptor down (SERD)-regulator (except fulvestrant for which a washout of at least 6 weeks is required).
- Inadequate hematological function.
- Inadequate renal function with serum creatinine ≥1.5 x upper limit of normal (ULN).
- Liver function: aspartate aminotransferase >3 x ULN, or alanine aminotransferase >3 x ULN. Total bilirubin >1.5 x ULN.
- Non-resolution of any prior treatment related toxicity to <Grade 2, except for alopecia
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 3920002
- Investigational Site Number 3920001
- Investigational Site Number 3920003
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SAR439859
Arm Description
administered orally once daily or twice daily as monotherapy in fasted or fed state
Outcomes
Primary Outcome Measures
Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
Incidence rate of study treatment-related DLTs at Cycle 1
Secondary Outcome Measures
Safety: Adverse Events (AEs)
Number of adverse events related to study therapy
Assessment of Pharmacokinetic parameter of SAR439859: tlag
Lag time, interval between administration time and the sampling time preceding the first concentration above the lower limit of quantification
Assessment of Pharmacokinetic parameter of SAR439859: tmax
First time to reach Cmax
Assessment of Pharmacokinetic parameter of SAR439859: Cmax
Maximum concentration observed
Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h
Area under the plasma concentration versus time curve over the dosing interval (24 hours, 10 hours or 12 hours)
Assessment of Pharmacokinetic parameter of SAR439859: Ctrough
Plasma concentration observed just before treatment administration during repeated dosing
Assessment of antitumor activity: Objective response rate (ORR)
Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Assessment of antitumor activity: Clinical benefit rate (CBR)
Clinical benefit rate is (CR [complete response] +PR [partial response] +SD [stable disease] ≥24 weeks) as per RECIST 1.1
Assessment of antitumor activity: Duration of response
Response duration defined as the time from initial response to the first documented tumor progression
Assessment of antitumor activity: Non-progression rate
Non-progression rate at 24 weeks (percentage of participants without progression at 24 weeks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03816839
Brief Title
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer
Acronym
AMEERA-2
Official Title
A Phase 1 Study for the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics Evaluation of SAR439859, Administered Orally as Monotherapy in Japanese Postmenopausal Women With Estrogen Receptor-Positive And Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer (AMEERA-2)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Primary Objective:
To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with estrogen receptor positive and human epidermal growth factor receptor 2-negative advanced breast cancer.
Secondary Objective:
To characterize the overall safety profile of SAR439859 administered as monotherapy.
To characterize the pharmacokinetic profile of SAR439859 administered as monotherapy.
To evaluate the antitumor activity of SAR439859 administered as monotherapy and the clinical benefit rate (complete response, partial response and stable disease ≥ 24 weeks).
Detailed Description
The duration of the study for an individual participant will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of at least 1 cycle (28 days) of study treatment, and an End of Treatment (EOT) visit at least 30 days (or until the participant receives another anticancer therapy, whichever is earlier) following the last administration of study treatment. Study treatment may continue until precluded by unacceptable toxicity, disease progression, or upon participant's request.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAR439859
Arm Type
Experimental
Arm Description
administered orally once daily or twice daily as monotherapy in fasted or fed state
Intervention Type
Drug
Intervention Name(s)
Amcenestrant (SAR439859)
Intervention Description
Pharmaceutical form: Capsules
Route of administration: Oral
Primary Outcome Measure Information:
Title
Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs)
Description
Incidence rate of study treatment-related DLTs at Cycle 1
Time Frame
Day 1 to Day 28
Secondary Outcome Measure Information:
Title
Safety: Adverse Events (AEs)
Description
Number of adverse events related to study therapy
Time Frame
Up to 30 days after administration of study treatment
Title
Assessment of Pharmacokinetic parameter of SAR439859: tlag
Description
Lag time, interval between administration time and the sampling time preceding the first concentration above the lower limit of quantification
Time Frame
Day 1 and Day 22 of Cycle 1 (28 days)
Title
Assessment of Pharmacokinetic parameter of SAR439859: tmax
Description
First time to reach Cmax
Time Frame
Day 1 and Day 22 of Cycle 1 (28 days)
Title
Assessment of Pharmacokinetic parameter of SAR439859: Cmax
Description
Maximum concentration observed
Time Frame
Day 1 and Day 22 of Cycle 1 (28 days)
Title
Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h
Description
Area under the plasma concentration versus time curve over the dosing interval (24 hours, 10 hours or 12 hours)
Time Frame
Day 1 and Day 22 of Cycle 1 (28 days)
Title
Assessment of Pharmacokinetic parameter of SAR439859: Ctrough
Description
Plasma concentration observed just before treatment administration during repeated dosing
Time Frame
Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2
Title
Assessment of antitumor activity: Objective response rate (ORR)
Description
Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Time Frame
64 weeks
Title
Assessment of antitumor activity: Clinical benefit rate (CBR)
Description
Clinical benefit rate is (CR [complete response] +PR [partial response] +SD [stable disease] ≥24 weeks) as per RECIST 1.1
Time Frame
64 weeks
Title
Assessment of antitumor activity: Duration of response
Description
Response duration defined as the time from initial response to the first documented tumor progression
Time Frame
64 weeks
Title
Assessment of antitumor activity: Non-progression rate
Description
Non-progression rate at 24 weeks (percentage of participants without progression at 24 weeks)
Time Frame
64 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Participants must be postmenopausal women.
Breast adenocarcinoma patients with locally advanced not amenable to radiation or surgery, inoperable and/or metastatic disease.
Either the primary or any metastatic site must be positive for estrogen receptor (ER) (>1% staining by immunohistochemistry).
Either the primary tumor or any metastatic site must be human epidermal growth factor receptor 2 non-overexpressing.
Patients with at least 6 months of prior endocrine therapy.
Exclusion criteria:
Eastern Cooperative Oncology Group Performance Status (ECOG) ≥2.
Significant concomitant illness that would adversely affect participation in the study.
Patients with a life expectancy less than 3 months.
Patient not suitable for participation, whatever the reason.
Major surgery within 4 weeks prior to first study treatment administration.
Treatment with strong and moderate cytochrome P450 3A inhibitors/inducers.
Patients with known endometrial disorders, uterine bleeding or ovarian cysts.
Treatment with anticancer less than 2 weeks before first study treatment.
Prior treatment with selective estrogen receptor down (SERD)-regulator (except fulvestrant for which a washout of at least 6 weeks is required).
Inadequate hematological function.
Inadequate renal function with serum creatinine ≥1.5 x upper limit of normal (ULN).
Liver function: aspartate aminotransferase >3 x ULN, or alanine aminotransferase >3 x ULN. Total bilirubin >1.5 x ULN.
Non-resolution of any prior treatment related toxicity to <Grade 2, except for alopecia
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 3920002
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 3920001
City
Kashiwa-Shi
Country
Japan
Facility Name
Investigational Site Number 3920003
City
Nagoya-Shi
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Learn more about this trial
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer
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