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Evaluation of Orally Administered SAR439859 in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03816839
Recruitment Status : Active, not recruiting
First Posted : January 25, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE January 17, 2019
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date October 8, 2020
Actual Study Start Date  ICMJE March 25, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2019)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
  • 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: AUC0-24 [ 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)
  • 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 (28 days) ]
    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 64 weeks (percentage of participants without progression at 64 weeks)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Orally Administered SAR439859 in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: SAR439859

Pharmaceutical form: Capsules

Route of administration: Oral

Study Arms  ICMJE Experimental: SAR439859
administered orally once daily or twice daily as monotherapy in fasted or fed state
Intervention: Drug: SAR439859
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03816839
Other Study ID Numbers  ICMJE TED15954
U1111-1217-2758 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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://www.clinicalstudydatarequest.com/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP