Evaluation of Orally Administered SAR439859 in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
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|ClinicalTrials.gov Identifier: NCT03816839|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : June 18, 2020
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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: SAR439859||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||March 25, 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
administered orally once daily or twice daily as monotherapy in fasted or fed state
Pharmaceutical form: Capsules
Route of administration: Oral
- Investigational medicinal product (IMP)-related dose limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 28 ]Incidence rate of study treatment-related DLTs at Cycle 1
- Safety: Adverse Events (AEs) [ Time Frame: Up to 30 days after administration of study treatment ]Number of adverse events related to study therapy
- Assessment of Pharmacokinetic parameter of SAR439859: tlag [ Time Frame: Day 1 and Day 22 of Cycle 1 (28 days) ]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 [ Time Frame: Day 1 and Day 22 of Cycle 1 (28 days) ]First time to reach Cmax
- Assessment of Pharmacokinetic parameter of SAR439859: Cmax [ Time Frame: Day 1 and Day 22 of Cycle 1 (28 days) ]Maximum concentration observed
- Assessment of Pharmacokinetic parameter of SAR439859: AUC0-24h or AUC0-10h and/or AUC0-12h [ Time Frame: Day 1 and Day 22 of Cycle 1 (28 days) ]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 [ Time Frame: Day 1, Day 8, Day 15 and Day 22 of Cycle 1 (28 days) and Day 1 of Cycle 2 ]Plasma concentration observed just before treatment administration during repeated dosing
- Assessment of antitumor activity: Objective response rate (ORR) [ Time Frame: 64 weeks ]Objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Assessment of antitumor activity: Clinical benefit rate (CBR) [ Time Frame: 64 weeks ]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 [ Time Frame: 64 weeks ]Response duration defined as the time from initial response to the first documented tumor progression
- Assessment of antitumor activity: Non-progression rate [ Time Frame: 64 weeks ]Non-progression rate at 24 weeks (percentage of participants without progression at 24 weeks)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816839
|Contact: Trial Transparency email recommended (Toll free number for US & Canada)||800-633-1610 ext 1 then #||Contact-US@sanofi.com|
|Investigational Site Number 3920002||Recruiting|
|Investigational Site Number 3920001||Recruiting|
|Investigational Site Number 3920003||Recruiting|
|Study Director:||Clinical Sciences & Operations||Sanofi|