SIENDO/ENGOT-EN5/GOG-3055: A Randomized Phase 3 Trial of Maintenance Selinexor Versus Placebo After Combination Platinum-based Chemotherapy in Advanced or Recurrent Endometrial Cancer Lead Presenter: Ignace Vergote, BGOG and University Hospitals Leuven, Leuven Cancer Institute Brief description of study The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. endometrial cancer. esophageal cancer. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. • The recommended phase II dose of selinexor was established as a 60 mg flat dose weekly in combination with CP. Endometrial cancer is a common gynecologic malignancy which frequently occurs in women of reproductive age. Interesting, a drug I hadn't heard of yet. Learn more. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Of the 14 patients treated, 12 (86 %) had at least one treatment-related adverse event (TRAE). Perlmutter Cancer Center gynecologic cancer experts offer personalized care for women with endometrial cancer. Use in Cancer Selinexor is approved to treat: Diffuse large B-cell lymphoma (certain types). Learn More. During the first quarter of 2019, an Investigational New Drug Application (IND) was submitted and accepted by FDA for a randomized, blinded Phase 2/3 study evaluating selinexor versus placebo as a maintenance therapy in patients with advanced or recurrent endometrial cancer following one prior platinum-based treatment. Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. 19-07-2021. "While selinexor has been most extensively studied in patients with hematologic malignancies, there is increasing evidence that selinexor may also play an important role in the treatment of a variety of solid tumors, including patients with endometrial cancer," said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. Selinexor demonstrated single-agent activity and disease control in patients with heavily pretreated ovarian and endometrial cancers. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Antengene Announces IND Approval in China for a Global Phase III Trial of Selinexor in Advanced or Recurrent Endometrial Cancer Shanghai and Hong Kong, PRC, May 12, 2021 -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class … Selinexor (XPOVIO®) is an US Food and Drug Administration (FDA) approved oral selective inhibitor of nuclear export that has been included in five regimens recommended by the National Comprehensive Cancer Network (NCCN®) Guidelines and multiple regimens recommended by the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines, for the treatment of … Patients with advanced disease that has relapsed or received prior platinum-based therapy or radiotherapy have limited options and the prognosis remains poor. Selinexor (KPT-330) Key Eligibility - Female, at least 18 years of age at the time of informed consent. At first glance a three-month delay to selinexor’s US FDA approval decision should be bad news for its developer, Karyopharm. We use cookies and similar tools to give you the best website experience. Title: SIENDO: Maintenance with selinexor/Placebo After Combination Chemotherapy i n Endometrial Cancer. Selinexor May Benefit Patients Ovarian or Endometrial Cancer Limiting Lynch Syndrome Screening in Endometrial Cancers May Be Harmful Across Racial Groups, Endometrial Cancer … The trial is being conducted over 80 centers across North America, Europe, and Asia and the results are expected in H2’2021 Antengene holds the exclusive development and […] Endometrial Cancer (The SIENDO study): A study evaluating once weekly selinexor as a maintenance therapy versus placebo in patients with endometrial cancer after first- or second-line chemotherapy Glioma (The KING study): An open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of selinexor in patients with recurrent gliomas With a high incidence rate that has continued to rise in recent years, endometrial cancer has become the most prevalent malignancy of the female reproductive tract. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. ... (STOMP), in liposarcoma (SEAL) and in endometrial cancer … Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study) Advanced or Recurrent Ovarian, Cervical, and Endometrial Cancer Treated With SHetA2 Social Interventions for Support During Treatment for Endometrial Cancer and Recurrence The Compatibility of Preoperative Endometrial … Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. - Carcinosarcoma of the uterus is also allowed. Selinexor may stop the growth of tumor cells by blocking a protein, called XPO1, that is needed for cell growth. Time from randomization until date of initiation of first therapy after discontinuation of study drug or death, whichever occurs first. Time from randomization until the second documented disease progression or death due to any cause by any cause on any subsequent line of anticancer therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Comprehensive Cancer Centers is currently running the following clinical research studies for endometrial cancers: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204) Study#: 20176. OncClub: Join the Chat on Trending Trials in Cancer BCMA as a Target in Heavily Pretreated Multiple Myeloma Expanding Treatment Options for HER2+ Breast Cancer … Selinexor demonstrated single-agent activity and disease control in patients with heavily pretreated ovarian and endometrial cancers. brain tumor. various types of lymphoma. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. non–small cell lung cancer. 17. Participants with endometrial carcinoma who had received at least one line of chemotherapy for relapsed or advanced (Stage IVb, IIIc) disease received a dose of 50 mg/m^2 of selinexor oral tablets BIW (doses at least 36 hours apart) with light meal and 120 mL of water in a 4-week treatment cycles. 16. Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at … Selinexor was safe and tolerable; side effects were predominantly grade 1/2. Endometrial cancer is most likely to come back within the first few years after treatment, so an important part of your treatment plan is a specific schedule of follow-up visits after treatment ends. But the group’s stock rose 30% today on hopes – however slim – that the multiple myeloma project might still be in line for … Selinexor is … The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Selinexor (also known as KPT-330) is a drug that works by trapping tumor suppressor proteins inside cancer cells, causing them to die or stop growing. NEWTON, Mass., May 26, 2021 / PRNewswire / -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that enrollment for its Phase 3 maintenance study evaluating selinexor in patients with endometrial cancer after combination chemotherapy is now recruiting eligible patients at participating hospitals in … ovarian cancer. FDA. Objective Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. It is used to treat multiple myeloma and a form of lymphoma; its use in this study is investigational. June 22, 2020. Online ahead of print. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. various types of leukemia. Selinexor (KPT-330) is a small molecule, oral, first-in-class, potent selective inhibitor of nuclear export (SINE) compound. ClinicalTrials.gov. Selinexor clinical trials are ongoing for its use in treating other conditions, including (15): soft-tissue sarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of selinexor (XPOVIO®) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the … Indication: Endometrial Cancer. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. Endometrial cancer is the most common cancer of the female reproductive tract and for patients who progress following initial chemotherapy there … Objective SIENDO is a Phase 3 study evaluating once weekly selinexor as a maintenance therapy versus placebo in patients with endometrial cancer after first- or second-line chemotherapy. Results Fourteen patients with the median age of 61 years (range, 22–68years) were treated, and the most common cancer types were gynecological cancers; ovarian (n = 5), endometrial (n = 2), and 1 each with fallopian tube and vaginal cancers. Interesting, a drug I hadn't heard of yet. Endometrial cancer, more commonly known as uterine cancer, is the most common cancer of the female reproductive system, with more than 130,000 new cases and 30,000 deaths in Europe in 2020. Imfinzi (durvalumab) has been approved in China for the first-line treatment of … The purpose of this research study is to see if selinexor can help keep endometrial cancer in remission. Accessed June 12, 2021. https://clinicaltrials.gov/ct2/ show/NCT03555422.
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