amcenestrant clinical trial

- To evaluate health related quality of life in the 2 treatment arms Listing a study does not mean it has been evaluated by the U.S. Federal Government. - To evaluate the pharmacokinetics of amcenestrant as single agent Amcenestrant is an oral SERD that antagonizes and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. Based on encouraging data emerging from our ongoing clinical program, we believe that amcenestrant, an investigational oral SERD, has the potential to become a … Pts are randomized 1:1 to either continuous amcenestrant 200 mg or letrozole 2.5 mg QD orally with matching placebos; both combined with palbo 125 mg QD orally (d1–21 every 28-d cycle). fluoroestradiol (18F-FES) uptake with increasing doses of amcenestrant Dose Escalation: In the AMEERA trials, we did observe that there was activity for amcenestrant regardless of whether the estrogen receptor was wild type or mutant. These include 5 functional scales, 3 symptom scales, a Global Health Status (GHS)/quality of life scale, and 6 single items. Brief Title: Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer Official Title: An Open Label Randomized Phase 2 Trial of Amcenestrant (SAR439859), Versus Endocrine Monotherapy as Per Physician's Choice in Patients With Estrogen Receptor-positive, HER2-Negative Locally Advanced or Metastatic Breast … - To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and ... Amcenestrant is an oral SERD that antagonizes and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. ICH GCP; US Clinical Trials Registry; Clinical Trials Nct Page; Phase 1 / 2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer - Residual ER availability with positron emission tomography (PET) scan [(18)F] This book presents comprehensive assessment and up-to-date discussion of the epidemiology, prevention, and treatment of cancer in the elderly, highlighting the growing demands of the disease, its biology, individual susceptibility, the ... Following is a transcript of her remarks: At San Antonio I had the pleasure of presenting the results from the AMEERA-1 trial. Randomization is stratified according to disease type (de novo metastatic vs recurrent disease), the presence of visceral metastasis, and menopausal status. Use of any investigational agent within 4 weeks prior to randomization, Recent use of hormone replacement therapy (last dose ≤30 days prior to randomization), Prior anti-cancer treatment is not allowed unless it was completed at least 1 year prior to inclusion into this trial, Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments), Inadequate hematological or renal function, Prothrombin time/international normalized ratio (INR) >1.5 x ULN or outside therapeutic range if receiving anticoagulation that would affect the prothrombin time/INR, Any of the following abnormal liver function test results: Aspartate aminotransferase >1.5 x upper limit of normal (ULN); Alanine aminotransferase >1.5 x ULN; Total bilirubin >1.5 x ULN, Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals, Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. combination with the selected amcenestrant dose for the combination therapy But there are important parallels between the delays, and both Sanofi and Gilead will now be able to review Radius’s full data at the San Antonio Breast Cancer Symposium before unveiling their own trials. Participant with any other cancer; adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed, Evidence of metastatic spread by standard assessment according to local practice, Treatment with strong Cytochrome P450 3A (CYP3A) inducers or drugs that have the potential to inhibit uridine diphosphate glucuronosyltransferase (UGT) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever is longest. This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the … PFS is defined as the time interval from the date of randomization to the date of documented tumor progression as per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) or death (due to any cause), whichever comes first. Remember, early detection is critical – to schedule a screening today, call (918) 744-5311. - To confirm the RD of amcenestrant in combination with alpelisib 4b-OH cholesterol, https://clinicaltrials.gov/show/NCT03284957, Primary Objectives: Sanofi partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT), which are world-leading academic groups delivering … To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Participants with known active hepatitis A, B, C infection; or hepatic cirrhosis. Why Should I Register and Submit Results? This book presents state-of-the-art diagnoses and treatments available for bladder cancer that has metastasised into the body. About the AMEERA-1 clinical trial AMEERA-1 is an open-label, Phase 1/2, first-in-human study designed to evaluate amcenestrant as a monotherapy and … Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms, To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms, To assess safety in the three treatment arms, Ki67≥50% [ Time Frame: Baseline and Day 15 ], ER Expression [ Time Frame: Baseline and Day 15 ], Adverse Events (AEs)/Serious Adverse Events (SAEs) [ Time Frame: Up to approximately Day 44 ], Clinical Laboratory Test Abnormalities [ Time Frame: Up to Day 14 ], Histological or cytological proven diagnosis of invasive breast adenocarcinoma, Localized breast cancer eligible for upfront breast conservative surgery or upfront mastectomy: Stage I, Stage II or operable Stage III (excludes T4) as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Talk with your doctor and family members or friends about deciding to join a study. Amcenestrant is an oral SERD that antagonizes and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. To determine whether amcenestrant per os improves progression free survival (PFS) when Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Treatment with drugs that are sensitive substrates of P-glycoprotein (P-gp) or of breast cancer resistance protein (BCRP) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever is longer. In the AMEERA trials, we did observe that there was activity for amcenestrant regardless of whether the estrogen receptor was wild type or mutant. alpelisib, everolimus, and abemaciclib - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in Antitumor activity at the RP2D for amcenestrant + palbo was evaluated in a subset of Part C pts and Part D, according to RECIST v1.1, determined locally by investigators. This Breast Cancer Awareness Month, we are proud to announce that the OCSRI and Ascension St. John teams at the Ascension St. John Mary K. Chapman Comprehensive Breast Center have already treated more than 5,000 of patients with preventative and life-saving care since opening in July 2021. About the AMEERA-1 clinical trial. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. This volume presents a comprehensive collection of detailed state-of-the-art protocols for gapmer-mediated RNA knockdown from leaders in the field. A listing of Metastatic Cancer medical research trials actively recruiting patient volunteers. This book will shed light on and emphasize intricate processes involved in designing as well as discovering physiological and pharmacological modulators of these important proteins. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. You can also search for a specific clinical trial using the field provided. metastatic or locally advanced breast cancer Data outlining amcenestrant as a frontline therapy can be expected from a Phase II AMEERA-3 trial in in 1H, as per an analyst report. Secondary Objectives: November 23, 2020. ... Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer. Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. When should I contact my doctor? What symptoms signal an emergency? Mayo Clinic Book of Home Remedies clearly defines these questions with regard to your health concerns and guides you to choose the appropriate and most effective response. Read our, ClinicalTrials.gov Identifier: NCT04191382, Interventional Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improvesprogression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. A multipart phase 1/2 first-in-human dose escalation trial has been conducted in women who are postmenopausal with hormone receptor-positive advanced breast cancer that’s been pretreated. - To evaluate the duration of response in the 2 treatment arms Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191382. This book describes recent advances in translational research in breast cancer and presents emerging applications of this research that promise to have meaningful impacts on diagnosis and treatment. - Overall safety profile of amcenestrant monotherapy and in combination Recently, the oral SERD amcenestrant has been added to the I-SPY2 Endocrine Optimization Protocol (EOP), where it will be evaluated as monotherapy or in combination with other targeted therapies, and several large adjuvant trials comparing oral SERDs to standard endocrine therapy have been announced [62,63]. Sanofi has partnered with academic cooperative groups for a Phase III clinical trial of amcenestrant as an adjuvant to treat patients with estrogen receptor-positive (ER+) breast cancer. Evaluation of Orally Administered Amcenestrant (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. Find a Clinical Trial. - To compare the overall survival in the 2 treatment arms Long before British humor master P.G. Wodehouse created the popular novel series based on the much-beloved character Jeeves, he sent up his native country's private school culture in A Prefect's Uncle. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. compared with a endocrine monotherapy of the choice of the physician, in participants with Late last year, the Phase 3 AMEERA-5 clinical trial investigating amcenestrant in combination with palbociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, as a first-line therapy for patients with ER+ metastatic breast cancer, was initiated. SAR439859 dose regimen 1 administered for 14 days, Pharmaceutical form: Capsules Route of administration: Oral, SAR439859 dose regimen 2 administered for 14 days, letrozole 2.5 mg administered once daily for 14 days, Pharmaceutical form: Tablets Route of administration: Oral, Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry) after a 14-day treatment period compared to baseline assessed by central reading, Proportion of participants with relative change from baseline in Ki67≥50% after a 14-day treatment period compared to baseline, Change in ER expression after a 14-day treatment period compared to baseline, Percentage of participants with clinical laboratory test abnormalities. Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer (AMEERA-3) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Brief Title: Phase 1 / 2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer Official Title: A Phase 1/2 Study for the Safety, Efficacy, Pharmacokinetic and Pharmacodynamics Evaluation of Amcenestrant (SAR439859), Administered Orally as Monotherapy, … Conclusions: In pts with ER+/HER2– mBC, safety at the RP2D of amcenestrant + palbo was favorable, with no safety signals of bradycardia or eye disorders. The EORTC-QLQ-C30 is composed of both multi item scales and single item measures. This thorough book aims to present the methods that have enabled the success of peptides and proteins in a wide variety of applications. Filter By: Clear Filters Benign Hematologic; Bladder; Breast; Cervical; Colon; Dermatologic The Clinical Trial, Re-Imagined The ground-breaking I-SPY 2 trial of neoadjuvant treatment for locally advanced breast cancer established a new benchmark for efficiency of phase II clinical trials. First-line ICIs or chemo-ICI trials have demonstrated OS advantages but the accrual was limited to Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1 patients. We have com piled contributions from numerous scientists well known for their work with several regulatory factors. In the following paragraphs, the reader will find an overview of the contents of this volume. As per the terms of the Pre-Study Agreement, Sanofi will be the sponsor and will provide funding and investigational drug product for the global study. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Administration of higher doses to subsequent participants is based on occurrence of DLTs and evaluation of target saturation and PK parameters at initial and subsequent doses, until maximum administered dose (MAD) is reached. Search for closest city to find … A valuable reference for urologists, oncologists, and those in specialty training, this volume provides ready access to information on etiology, incidence, risk factors, diagnosis, prognosis, insights from molecular pathology and, where ... ICI studies have for the vast majority excluded patients with poor performance status. Clinical Trials Search at Vanderbilt-Ingram Cancer Center. About the AMEERA-1 clinical trial. Primary Objective: To determine whether amcenestrant given at 2 different doses improves the antiproliferative activity when compared to letrozole Secondary Objectives: - To assess the proportion of participants with a relative decrease from baseline in percentage of positive tumor cells tested by immunohistochemistry ≥50% (Ki67≥50%) in the three treatment arms - To … Secondary Objectives: Giredestrant, amcenestrant and camizestrant are in phase 3 trials investigating combination use with Sanofi’s CDK inhibitor Ibrance (palbociclib) … Amcenestrant is currently under clinical investigation and its safety and efficacy have not … Such selected concepts that redefine medicinal and natural product chemistry have been presented in this book. The extensive content presented in the book provides the readers with a thorough understanding of this subject. Clinical Trial Calendar ... Amcenestrant is an oral SERD that antagonizes and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. This is important because Sanofi’s Ameera-3 trial of amcenestrant allows up to 20% of enrolees to be CDK4/6-naive, which together with the order of therapy makes the outcome of this trial hard to call. About the AMEERA-1 clinical trial. Breast cancer is one of the leading causes of cancer mortality in women worldwide. For patients with hormone receptor-positive breast cancer, some form of endocrine therapy is central to managing their disease. Treatment will begin with an identified starting dose. Part A: Amcenestrant will be administered orally once daily (QD). AMEERA-1 is an open-label, Phase 1/2, first-in-human study designed to evaluate amcenestrant as a monotherapy and in combination with targeted therapies in postmenopausal women with ER+/HER2- MBC. Amcenestrant is currently under clinical investigation and its safety and efficacy have not been evaluated by any regulatory authority. Below is a list of currently active Phase I, II, III and IV trials. The Forty-seventh WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted 26 new monographs and general texts for inclusion in The International Pharmacopoeia,/I>. Sanofi partnering with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC) and Alliance Foundation Trials (AFT), which are world-leading academic groups delivering … Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/. AFT, a cancer clinical trial research organization, will handle the U.S. portion of the study. Sanofi partnering with leading academic cooperative groups to study amcenestrant in the adjuvant setting for patients with estrogen receptor positive breast cancer. The ESR1 Mutated Metastatic Breast Cancer pipeline therapies include Elacestrant (RAD1901), Amcenestrant (SAR439859), Rintodestrant (G1T48), ... As per the secondary domain searches and exploring clinical trials site, it has been observed that very few clinical trials had been registered for this indication. This is a phase I/II trial, which evaluated oral amcenestrant… Metastatic Cancer Clinical Trials. - Antitumor activity using objective response rate (ORR) Safety Run-In: - Food effect on PK of amcenestrant Information provided by (Responsible Party): Duration of the study, per patient, will include screening period of up to 14 days before randomization, treatment period of 14 days and post-treatment safety follow-up period of 30±7 days after last Investigational Medicinal Product (IMP) intake. Clinical Trials A randomized, multicenter, double-blind Phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease. Amcenestrant is an oral SERD that antagonizes and degrades the estrogen receptor (ER), resulting in inhibition of the ER signaling pathway. You have reached the maximum number of saved studies (100). The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning ... We call this “infoimagery”. OS is defined as the time interval from the date of randomization to the date of documented death (due to any cause). and the centerwatch system associates the information to a matching set of related symbols and icons. - To assess the incidence rate of DLT and determine the RD of everolimus or abemaciclib in maximum tolerated dose (MTD) as well as the recommended dose (RD) of, Cycle 1, Day 28 for each treated participant (each cycle is 28 days), Number of participants with adverse events according to the National, Baseline to the date of first documentation of progression, assessed approximately up to 6 months after the last entered participant, Proportion of participants with complete response (CR) or partial response (PR) according to RECIST 1.1 assessed by investigator/local radiologist relative to the total number of treated participants in all, Proportion of participants with CR or PR or SD ≥24 weeks according to RECIST v.1.1 relative to the total number of treated participants by investigators/local radiologists in all, Time from initial response to the first documented tumor progression in all, Cycle 1, Day 1 and Day 3 (each cycle is 28 days), tlag is interval between administration time and the sampling time preceding the first concentration above the lower limit of quantification of, AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) (, Cycle 1, Day 21 or 22 (each cycle is 28 days), Cmax is maximum concentration observed in all, AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) in all, Cycle 1, Day 8, Day 21 or 22 and Cycle 2, Day 1 (each cycle is 28 days), Ctrough is plasma concentration observed just before, Cmax is maximum concentration observed (Arm #2), AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) (Arm #2), Plasma 4B hydroxy/total cholesterol concentration ratios (Arm #1), Baseline and one assessment in Cycle 1 on Day 11 to 15 (each cycle is 28 days), Time interval from the date of the first IMP intake to the date of the first tumor progression assessed by investigators/local radiologists in all, Baseline and approximately at Day 15 of Cycle 1 in Part A (each cycle is 28 days), Cmax is maximum concentration observed (Arm #3), AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) (Arm #3), Cmax is maximum concentration observed (Arm #4), AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) (Arm #4), Cmax is maximum concentration observed (Arm #5), AUC0-24 is area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (24 hours) (Arm #5).
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