Condition or disease Intervention/treatment . Nirogacestat: Uses, Interactions, Mechanism of Action - DrugBank Free dental implants clinical trials near me 2022 First Patient Dosed in Trial of Belantamab Mafodotin, Nirogacestat Apply to this Phase 3 clinical trial treating Fibroma, Fibromatosis, Aggressive, Desmoid Tumors, Aggression. Nirogacestat - Desmoid Treatment - SpringWorks Therapeutics Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the . 21-147 - ARST1921 - A Study of a New Drug, Nirogacestat, for Treating In the DREAMM-5 Phase I/II platform trial BLENREP (belantamab mafodotin), a BCMA-targeting antibody-drug conjugate, is being evaluated in combination with nirogacestat to determine if the combination can result in similar efficacy and an improved ocular safety profile compared to the currently approved belamaf schedule (single agent dose 2.5 mg . Apply to this Phase 2 clinical trial treating Unresectable Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis, Fibroma, Fibromatosis, Aggressive, Fibromatosis Desmoid. Free dental implants clinical trials near me 2022 -Treatment with the selective small-molecule Gamma-secretase inhibitor Nirogacestat caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early phase clinical trial. Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors. Summary. New Nirogacestat Combos to Enter Myeloma Trials, SpringWorks Says This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). NIH Clinical Center Search the Studies: Study Number, Study Title Trade Name: Nirogacestat: Generic: Nirogacestat: Nirogacestat Other Names: Nirogacestat: Type: Formula: C 27 H 41 F 2 N 5 O: You may also receive a new research . People take part in clinical trials for many reasons. Nirogacestat for fibroma Clinical Trial 2022 | Power - withpower.com PDF SpringWorks Therapeutics Announces Clinical Collaboration with Pfizer Nirogacestat (PF-03084014) is a potent, small molecule, selective, reversible, noncompetitive inhibitor of -secretase (GS) with a potential antitumor activity. SpringWorks Therapeutics Announces Nirogacestat Achieved Primary and Desmoid Tumors: Phase 3 Clinical Trial Data With Nirogacestat Shows The tooth extraction may come between $75 to $200 per tooth. Title IX Headlines on One News Page Learn more. Nirogacestat in Ovarian Granulosa Cell Tumors - Full Text View Rejestr bada klinicznych. About Nirogacestat. Protocol ID. UCSF Multiple Myeloma Trial: Safety and Clinical Activity of PBCAR269A A Phase 2 Trial of Nirogacestat in Patients With Recurrent Ovarian Serum Concentrations of Nirogacestat [ Time Frame: Up to 2 year and 5 months ] Serum concentration of nirogacestat will be reported. | CheckRare is a learning platform for health care professionals and patients. Clinical Trials - Cleveland Clinic About Nirogacestat. For example, you could advance understanding of a disease and help others like yourself. Use the filters below to find active studies currently open for enrollment. Nirogacestat oral tablet for Fibromatosis, Aggressive Clinical Trial Listing a study does not mean it has been evaluated by the U.S. Federal Government. DOI: 10.1200/PO.21.00228 JCO Precision Oncology no. Leading Publisher and Learning Platform Focused on Rare Diseases. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Nirogacestat (PF-03084014) is a selective gamma secretase inhibitor developed by SpringWorks Therapeutics that has potential anti-tumor activity. Nirogacestat - Wikipedia SpringWorks Therapeutics Announces Dosing of First Patient in Phase 2 Phase III Trial for Nirogacestat A new company named SpringWorks Therapeutics has been formed as a spinoff of Pfizer to focus on investigational therapies that hold significant promise for underserved populations. Get access to cutting edge treatment via Nirogacestat oral tablet, Placebo Oral Tablet. Study subjects in Cohort A will receive PBCAR269A and study subjects in Cohort B will receive PBCAR269A and nirogacestat. A.3.1: Title of the trial for lay people, in . A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors that Nirogacestat has been used in trials studying the treatment of Breast Cancer, HIV Infection, Desmoid Tumors, Advanced Solid Tumors, and Aggressive Fibromatosis, among others. SpringWorks Therapeutics announced new collaborations with two companies, Pfizer and Janssen, to investigate its oral therapy candidate nirogacestat in combination with BCMA-targeting agents to treat people with relapsed or refractory multiple myeloma. Nirogacestat is currently in Phase 2 clinical trials . The collaboration with Pfizer aims to test nirogacestat plus PF06863135 in a Phase 1b/2 . This study aims to enroll a total of 140 patients (140 implants ) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. ARST1921: A Study of a New Drug, Nirogacestat, for Treating Desmoid The PBCAR269A clinical trial is being conducted at multiple U.S. sites. A Study of Nirogacestat for Adults With Desmoid Tumor/Aggressive Ovarian Cancer Clinical Trial: Nirogacestat in Ovarian Granulosa Cell Individual Patient Compassionate Use of Nirogacestat. ARST1921 NCI-2019-07498 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) ARST1921 ( Other Identifier: Children's Oncology Group ) ARST1921 ( Other Identifier: CTEP ) U10CA180886 . Find a Clinical Trial - Emory University Our platform allows users to gain insight and learn about rare diseases, current and emerging therapies, clinical trials, and the BioPharma companies behind them. Nirogacestat. DREAMM-5 Study: BLENREP Combined with Nirogacestat Presented at ASCO 2022 Nirogacestat has been used in trials studying the treatment of Breast Cancer, HIV Infection, Desmoid Tumors, Advanced Solid Tumors, and Aggressive Fibromatosis, among others. PMID: 34994644 Generic Name. The FDA has granted nirogacestat (PF-03084014), an investigational gamma-secretase inhibitor, with a breakthrough therapy designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. Find a Clinical Trial 21-147 - ARST1921 - A Study for Treating Desmoid Tumors That . It was granted FDA breakthrough drug designation in September 2019 for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.. Medical uses []. People's involvement in clinical trials helps researchers uncover better ways to treat, prevent, diagnose, and understand different diseases and medical conditions. DB12005. . 2145- 10.17.2022). Show: NCT ID. The DeFi (Desmoid/Fibromatosis) trial is a Phase 3 clinical trial designed to evaluate the safety, efficacy and tolerability of an investigational drug called nirogacestat in people over the age of 18 with progressing desmoid tumors. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bernd Kasper, MD, PhD, University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany and Principal Investigator of the phase 3 DeFi clinical trial, discusses the impressive results of the trial, which evaluated nirogacestat in the treatment of desmoid tumors. that the company has entered into a clinical trial collaboration agreement with Pfizer Inc. (NYSE: PFE) to evaluate SpringWorks Therapeutics' investigational gamma secretase . Desmoid tumors can grow anywhere on the body into surrounding healthy tissues, including joints, muscle, and viscera. Treatment. SpringWorks Therapeutics Announces Dosing of First Patient in - Yahoo! Our peer-to-peer content is a trusted source . Nirogacestat is being investigated for the treatment of desmoid tumors due to its ability to bind to GS, blocking proteolytic activation of Notch receptors. It is scheduled to be annotated soon. This study evaluates nirogacestat (PF-03084014) in the treatment of desmoid tumor/aggressive fibromatosis (DT/AF). Nirogacestat (PF-03084014) is a potent, small molecule, selective, reversible, noncompetitive inhibitor of -secretase (GS) with a potential antitumor activity. Nirogacestat (PF-03084014) is a selective gamma secretase inhibitor developed by SpringWorks Therapeutics that has potential anti-tumor activity. SpringWorks is conducting a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial (the DeFi trial) to evaluate the efficacy, safety, and tolerability of nirogacestat in adult patients with progressing desmoid tumors (NCT03785964). Precision BioSciences and SpringWorks Therapeutics Dose - Business Wire CheckRare on LinkedIn: Desmoid Tumors: Phase 3 Clinical Trial Data With The FDA has granted nirogacestat (PF-03084014), an investigational gamma-secretase inhibitor, with a breakthrough therapy designation for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Study Type The nature of the investigation or investigational use for which clinical study information is being submitted. Participant has known malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat (e.g., gastric bypass, lap band, or other gastric procedures that would alter absorption); delivery . This drug entry is a stub and has not been fully annotated. This phase II trial studies the side effects and how well nirogacestat works in treating patients patients less than 18 years of age with desmoid tumors that has grown after at least one form of treatment by mouth or in the vein that cannot be removed by surgery. Clinical Trials Register Exclusion Criteria. 1 The breakthrough designation was granted as a result of positive findings seen in phase I and II trials of nirogacestat monotherapy . -The Notch pathway is a key regulator of cell differentiation, proliferation and apoptosis; aberrant signaling via the Notch pathway is associated . This phase II trial studies the side effects and how well nirogacestat works in treating patients patients less than 18 years of age with desmoid tumors that has grown after at least one form of treatment by mouth or in the vein that cannot be removed by surgery. ICH GCP. UCSF Desmoid Tumor Trial: New Drug, Nirogacestat, for Treating Desmoid 5 (2021) 1579-1583. A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Phase 2 Trial of Nirogacestat Doses First Patient With Ovarian . Purpose. Nirogacestat | C27H41F2N5O - PubChem Nirogacestat. View duration, location, compensation, and staffing details. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has eight collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities . Individual Patient Compassionate Use of Nirogacestat 201 Considered by the investigator to have rapid clinical progression due to melanoma. First Drug for Desmoid Tumors: 'Impressive' Data for Nirogacestat The safety and preliminary effectiveness of this combination are being assessed as a sub . Nirogacestat for Adults With Desmoid Tumor - Stanford Health Care Placebo-Controlled, Phase 3 Trial of Nirogacestat Versus Placebo in Adult Patients with Progressing Desmoid Tumors/Aggressive Fibromatosis (DT/AF). For more information, contact our Clinical Trials Office at (404) 778-1868. 1 The breakthrough designation was granted as a result of positive findings seen in phase I and II trials of nirogacestat monotherapy . ARST1921: A Safety, Pharmacokinetic and Efficacy Study of a y-Secretase Inhibitor, Nirogacestat (PF-03084014) in Children and Adolescents With Progressive, Surgically Unresectable Desmoid Tumors. This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Badanie kliniczne dotyczce Szpicak mnogi: Belantamab Mafodotin Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors. Know the risks and potential benefits of clinical studies and talk to your health care provider . The main objective of the intervention(s) being evaluated by the clinical trial. Get access to cutting edge treatment via Nirogacestat, Questionnaire Administration, Quality-of-Life Assessment. The Real Story of Good Health ~ in 120 Seconds or Less. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has eight collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities . CheckRare | 2,564 followers on LinkedIn. This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR269A, with or without nirogacestat, in adults with r/r MM. NIROGACESTAT - Drug Approvals International . Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Upcoming Clinical Trials - Desmoid Tumor Research Foundation In the double-blind phase, half of the participants will receive nirogacestat while the other half will receive placebo. In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi . Physician. Ricardo Dolmetsch, PhD, President of Research and Development at uniQure, discusses positive data from the low-dose cohort of the ongoing phase 1/2 clinical trial of AMT-130, the first-ever AAV . Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors. Trial Name. Nirogacestat | C27H41F2N5O | CID 46224413 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities . ARST1921 - A Safety, Pharmacokinetic and Efficacy Study of a -Secretase Inhibitor, Nirogacestat (PF-03084014; IND# 146375), in Children and Adolescents with Progressive, Surgically Unresectable Desmoid Tumors Desmoid Tumors that cannot be removed by surgery . Published online October 6, 2021. Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 . A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That In addition, a Phase 3 clinical trial, DeFi, is currently in progress for nirogacestat for adults with desmoid tumors and aggressive fibromatosis. Let's share, debate and celebrate all the new developments that we can bring to our practice. Nirogacestat showed improved progression-free survival, pain scores, symptoms, and quality of life in patients with progressive desmoid tumors in a phase 3 trial hailed as 'practice changing.' 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 . AFLDS.org with Dr. Peterson Pierre presents Daily Dose: 'Title IX: What Parents Need to Know?' (Ep.
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