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Treatment of granulosa cell tumors with nirogacestat is expected to inhibit Notch-induced granulosa cell proliferation. CAS#: 1290543-63-3 (free base) Description: Nirogacestat, also known as PF-03084014, is a potent and selective gamma secretase (GS) inhibitor with potential antitumor activity. Failure as a monotherapy has spurred combinatorial regimens. Nirogacestat has been used in trials studying the treatment of Breast Cancer, HIV Infection, . Stem cell therapy is expected to be used in the treatment of POI. This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Nirogacestat (PF-03084014) Investigational Device(s) None . Premature ovarian insufficiency (POI) or premature ovarian failure (POF) is known as a state of hypergonadotropic hypogonadism. Nirogacestat enhances the Antitumor Effect of Docetaxel in Prostate Cancer. Share this article. [2] Premature ovarian insufficiency (POI), defined as amenorrhoea due to the loss of ovarian function before 40 years of age, can occur spontaneously or be secondary to medical therapies. Phone: 855-776-0015 (toll-free) International patient clinical studies questions. It has been suggested that POI may affect 1% of women under 40 [1,3,4]. Primary (or premature) ovarian insufficiency * is a clinical syndrome defined by the loss of ovarian function before the age of 40 years. Nirogacestat (PF-03084014, PF), a novel gamma-secretase inhibitor, has been used in phase II clinical trial for treatment of desmoid tumor. Bone Loss and Fracture Risk. ChemSpider ID 26232306. 1 It is characterised by menstrual irregularities (infrequent menstrual cycles or amenorrhoea) with elevated FSH and LH levels and low oestradiol levels. About the Phase 2 Trial of Nirogacestat Trial Name: Nirogacestat in Ovarian Granulosa Cell Tumors ClinicalTrials.gov Indentifier: NCT05348356 September 4, 2019. ; Osteoporosis: Estrogen is a hormone that keeps bones dense and strong.Without an adequate supply, the bones weaken and are more likely to break. Nirogacestat is being investigated for the treatment of desmoid tumors due to its ability to bind to GS, blocking proteolytic activation of Notch receptors. Nirogacestat was generally well tolerated with a manageable safety profile. Primary ovarian insufficiency (POI) is a condition resulting from the depletion or dysfunction of the ovarian follicles, leading to cessation of ovulation and menses before age 40. Ovarian granulosa cell tumors (OvGCTs) represent 5-7% of all ovarian cancers (~1.5 to 2k newly diagnosed patients/year in the United States) and are the most common subtype of ovarian sex cord tumors (70%). Metabolic dysregulation in patients with premature ovarian insufficiency revealed by integrated transcriptomic, methylomic and metabolomic analyses Clin Transl Med . The disease can be either asymptomatic or be associated with severe loss of . In women with this condition, the ovaries (organs that produce a woman's eggs) stop producing eggs before age 40. 12-09-2022. Reduce drug development failure rates. Nirogacestat - SpringWorks Therapeutics Alternative Names: Nirogacestat hydrobromide; PF 3084014; PF-03084014; PF-03084014-04 Latest Information Update: 04 Oct 2022 Price : $50 * Buy Profile Adis is an information provider. Ovary Insufficiency. Ovarian insufficiency occurs in approximately 1% of women. Nirogacestat (PF-03084014) is a potent, small molecule, selective, reversible, noncompetitive inhibitor of -secretase (GS) with a potential antitumor activity. The study will enroll approximately 40 patients who will receive 150mg of nirogacestat twice daily. In the double-blind phase, half of the participants will receive nirogacestat while the other half will receive placebo. Find out more about your treatment options, how . In terms of safety, nirogacestat had a manageable safety profile and was well tolerated. Kineta, a privately-held immuno-oncology company, has announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co. Primary ovarian insufficiency (POI), also known as premature ovarian failure, happens when a woman's ovaries stop working normally before she is 40. The Phase 2 trial (NCT05348356) is a multi-center, single-arm, open-label study evaluating the efficacy, tolerability, safety, and pharmacokinetics of nirogacestat in patients with recurrent . . Different experimental approaches are being explored . Gynecologic anomalies, including uterine agenesis and ovarian dysgenesis, are some of the several differential diagnoses in adolescent females with primary amenorrhea and delayed puberty. This compound can inhibit both Notch-related pathway in neoplasia and reduces amyloid- production. The aim of the present study was to explore the feasibility and effectiveness of umbilical cord mesenchymal stem cell (UCMSC) transplantation for the treatment of POI in a rat model of POI induced by . Typical symptoms found when the menopause occurs later, such as hot flushes and night sweats, may not be present. symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. The study will enroll approximately 40 patients who will receive 150mg of nirogacestat twice daily. In the case of ovarian cancer, . The estimated incidence is: by age 20: 1:10,000. by age 30: 1:1000. by age 35: 1:250. by age 40: 1:100. - Mechanism of Action & Protocol. - Participant has an abnormal QT interval at screening. SpringWorks Therapeutics Announces Dosing of First Patient in Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian. Ovarian Cancer / Ovarian Granulosa Cell Tumor / Ovarian Granulosa-Stromal Tumor: 1: 2: National Cancer Institute. The Phase 2 trial ( NCT05348356) is a multi-center, single-arm, open-label study evaluating the efficacy, tolerability, safety, and pharmacokinetics of nirogacestat in patients with recurrent. There are currently two active clinical trials of nirogacestat as a treatment for Desmoid tumors. Nirogacestat | C27H41F2N5O | CID 46224413 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . Primary ovarian insufficiency is reported in the clinical practice of reproductive endocrinology can be determined by conducting sex hormone tests to evaluate the hypothalamic-pituitary-ovarian axis. Premature ovarian insufficiency (POI) occurs in women aged under 40 years and is a syndrome consisting of amenorrhoea, elevated gonadotrophins and oestrogen deficiency. The FDA has granted a breakthrough therapy designation to the investigational gamma-secretase inhibitor nirogacestat (PF-03084014) for the treatment of adult . Supporting Site. When adolescents present with primary amenorrhea and no associated comorbidities, 50% are found to have abnormal karyotypes. Primary ovarian insufficiency is when the ovaries lose function before age 40. Background. 1 The breakthrough designation was granted as a result of positive findings seen in phase I and II trials of nirogacestat monotherapy . Nirogacestat is an investigational oral, selective, small molecule gamma secretase inhibitor (GSI) in Phase 3 clinical development for adult patients with progressing desmoid tumors and in Phase 2 clinical development for patients with ovarian granulosa cell tumors. Nirogacestat, a selective gamma-secretase inhibitor, has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 studies; the Company is planning a Phase 3 study (DeFi . - 2 of 2 defined stereocentres. Heart disease: When estrogen levels are low, cholesterol is more likely to build up in the . Nirogacestat (PF-3084014) is a reversible, orally bioavailable, noncompetitive, and selective -secretase inhibitor with an IC50 of 6.2 nM. In the double-blind phase, half of the .. . Intervention(s) Drug: PF-03084014. Premature ovarian insufficiency (POI) is the loss of normal ovarian function before the age of 40 years, a condition that affects approximately 1% of women under 40 years old and 0.1% of women under 30 years old. STAMFORD, Conn., Sept. 29, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for . As Dr. Cassidy explains, nirogacestat is an oral, selective, small molecule, gamma-secretase inhibitor. 4 Nirogacestat elicited an ORR of 29.4%, with no progressive. Primary ovarian insufficiency: an overview. Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The usual age for egg production to stop, known as menopause, is around 50. Notably, most individuals capable of bearing children experienced an adverse effect that was consistent with ovarian dysfunction, although most toxicities were consistent with previously reported findings. Treatment of granulosa cell tumors with nirogacestat is expected to inhibit Notch-induced granulosa cell proliferation. This can lead to infertility and a higher risk for other conditions. The purpose of this study is to assess the safety and toxicity of ABBV-383 when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), daratumumab-dexamethasone (Dd), or nirogacestat (Niro) in adult participants with relapsed/refractory (R/R . doi: 10.1002/ctm2.1006. 1 Approximately one in 100 women aged < 40 years and one in . Trial Description: This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Primary ovarian insufficiency is suspected in women < 40 with unexplained infertility, menstrual abnormalities, or symptoms of estrogen deficiency. Some genetic disorders are associated with primary ovarian insufficiency. POI is not an early menopause. nirogacestat. They may start getting irregular menstrual periods as they transition to menopause. Full Title A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014, IND 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors (ARST1921) (CIRB) Purpose The purpose of this study is to assess the safety and effectiveness of the investigational drug nirogacestat in children and adolescents with desmoid tumors that . Protocol Number Title Protocol Status Min-Max Age Institute Keywords: 000760-H: Extension Study (extended access) of Syk-inhibition Using Fostamatinib to Treat Post-Transplant Immune-mediated Cytopenias Inhibition of Notch signaling by Nirogacestat while minimizing gastrointestinal toxicity presents a promising approach for research of Notch receptor-dependent cancers. Nirogacestat, also known as PF-03084014, is a potent and selective gamma secretase (GS) inhibitor with potential antitumor activity. SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe MedKoo CAT#: 525757. This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). Heterogeneity of POI is registered by . A pregnancy test is done, and serum FSH and estradiol levels are measured weekly for 2 to 4 weeks; if FSH levels are high ( > 20 mIU/mL, but usually > 30 mIU/mL) and estradiol levels are low . This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Ovarian insufficiency is a failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ. A pregnancy test is done, and serum FSH and estradiol levels are measured weekly for 2 to 4 weeks; if FSH levels are high ( > 20 mIU/mL, but usually > 30 mIU/mL) and estradiol levels are low . Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which may contribute to desmoid tumor growth. These include conditions in which you have one typical X chromosome and one altered X chromosome (mosaic Turner syndrome) and in which X chromosomes are fragile and break (fragile X syndrome). The final analysis of the Phase III LEAP-002 trial investigating Lenvima (lenvatinib), discovered by Japan's Eisai plus US pharma giant Merck & Co's mega blockbuster Keytruda (pembrolizumab) versus Lenvima monotherapy, was inconclusive for the combination as first-line treatment for patients with . Patient management. Among younger women (aged 30 years or younger) with secondary amenorrhea, 13% also have been noted . Primary ovarian insufficiency is suspected in women < 40 with unexplained infertility, menstrual abnormalities, or symptoms of estrogen deficiency. Among important research news last week, US pharma giant Merck & Co released positive Phase III results for the pulmonary arterial . Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors. The Phase 2 trial (NCT05348356) is a multi-center, single-arm, open-label study evaluating the efficacy, tolerability, safety, and pharmacokinetics of nirogacestat in patients with recurrent ovarian granulosa cell tumors. Nirogacestat ( PF-03084014) is a selective gamma secretase inhibitor [1] developed by SpringWorks Therapeutics that has potential anti-tumor activity. Molecular Formula CHFNO. Primary ovarian insufficiency is primarily idiopathic, but it can also be seen in association with chromosomal and genetic defects, including Turner syndrome (45,X . Lisa Astor. It was granted FDA breakthrough drug designation in September 2019 for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. (Nirogacestat) has spurred the phase III trial in adult patients with desmoid tumors (NCT03785964), recent breakthrough designation by the U.S. Food and Drug Administration, and orphan drug designation by the European Commission. ICH GCP. Gamma-secretase, a proteolytic enzyme complex, mediates processing of several integral membrane proteins including amyloid precursor protein and Notch. Cancer-related trials contact form. Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors.. Clinical Trials Registry. Women with primary ovarian insufficiency-related estrogen deficiency are at risk of osteopenia, osteoporosis, and fracture, especially if hypoestrogenism occurs early in life and before accrual of peak bone mass 3 12 13 14.In studies that have evaluated the role of HT in women at elevated risk of fracture based on menopausal age, significant reductions in fracture . Final gross price and currency may vary according to local VAT and billing address. Again, the median PFS had not yet been reached at the time of the publication data because of a lack of tumor progression events. This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.

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