Leuk Res. The study doctor can explain how the study drug is designed to work. Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients With Myelodysplastic Syndrome With Excess Blasts Progressing On or After Azacitidine or Decitabine This information was retrieved directly from the website clinicaltrials.gov without any changes. Information provided by (Responsible Party): This study, is a Phase I/II clinical trial in three parts: Phase I Dose Escalation, Phase II, Part 1 RPTD Cohort, and Phase II, Part 2 Expansion. Geographic region (North America vs Europe vs Asia; because approved products and standard of care may vary by region), and randomly assigned in a 2:1 ratio to one of the following 2 treatment groups: Rigosertib 1800 mg/24 hr administered as a 72 hr CIV infusion on Days 1, 2, and 3 of a 2 week cycle for the first 8 cycles, and on Days 1, 2, and 3 of a 4-week cycle thereafter (N = approximately 240 patients); Physician's Choice of alternative treatment, which may include any approved or standard-of-care therapy that the patient has not shown to be hypersensitive to, based on frequently used treatment for MDS, as per institutional guidelines, after receipt of HMAs (N = approximately 120 patients). For IV treatment Rigosertib 1800 mg/24 hr is diluted in 0.9% sodium chloride for injection just prior to dosing and is administered as a 72-hr CIV infusion on days 1, 2, and 3 of a 2-week cycle for the first eight 2-week cycles, then on days 1, 2, and 3 of a 4-week cycle thereafter. Found inside – Page 242Schroeder, Tolman & McKenna (2014) Drug Alcohol Depend. 142, 41. N HO H OH OH ... results of a recent clinical trial in hunans suggest celgosivir does not significantly reduce viral load or fever burden in patients with dengue (2). Major surgery without full recovery or within 3 weeks before planned randomization; New onset seizures (within 3 months before planned randomization) or poorly controlled seizures, Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or corticosteroids (prednisone up to 20 mg/day or its equivalent is permitted for chronic conditions), Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the treatment of MDS (other than growth factors and other supportive care measures) within 4 weeks of planned randomization, Investigational therapy within 4 weeks of planned randomization. Found inside – Page 36Further problems in drawing conclusions regarding the efficacy of VDDs in AML based on the clinical trials reported to ... Examples of Target Compounds Phase Status of the study studies Cell cycle inhibition rigosertib volasertib I/II I ... Phase 1/2a (NCT04263090) This is an open-label, Phase 1/2a study incorporating a dose-escalating stage followed by a dose-expansion stage to study the combination of rigosertib and nivolumab in metastatic Kirsten rat sarcoma positive (KRAS+) lung adenocarcinoma patients who have … As reported in OncLive, intravenously-administered rigosertib failed to meet the primary endpoint within the Phase 3 INSPIRE clinical trial. Ultimately, the trial sought to understand whether rigosertib could improve overall survival rate in patients with higher-risk myelodysplastic syndromes (HR-MDS). Oral rigosertib will be administered twice a day in fasting conditions for weeks 1, 2, and 3 of a 4-week cycle. 2016 Aug;16(8):805-10. doi: 10.1080/14737140.2016.1209413. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Advanced clinical trials with our lead compound, rigosertib, are aimed at unmet medical needs of patients with myelodysplastic syndromes (MDS). Found insideMany PI3Kinhibitorsare currently beinginvestigated inbothpreclinical and clinical settings. ON 01910.Na (rigosertib), a multikinase PI3K inhibitorin phaseIIItrials for myelodysplastic syndrome, has demonstrated promising preclinical in ... Investigational therapy within 4 weeks of Screening. Genetic and Rare Diseases Information Center, Myelodysplastic Syndrome With Excess Blasts. Female patients who are pregnant or lactating. Patients in both the rigosertib arm and the control arm will be monitored closely throughout the trial and hospital stays are not required. Serum creatinine ≥2.0 mg/dL or eGFR (estimated Glomerular Filtration Rate) < 40 mL/min. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. It is currently being used for research purposes only. ], Percent of patients with bone marrow blast response rate according to 2006 IWG criteria. MDS is a hematological malignancy resulting in bone marrow failure which leads to acute myeloid leukemia (AML) in 30% of high-risk patients. of Dermatology University Hospital, Contact: Elisabeth Mayr, PhD    +4357255 ext 82413, Contact: Sophie Kitzmüller, PhD    +4357255 ext 52053, Department of Dermatology, Paracelsus Medical University, Salzburger Landeskliniken, Prof. Johann Bauer, Head of Department of Dermatology, Salzburger Landeskliniken. Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. Athuluri-Divakar SK, Vasquez-Del Carpio R, Dutta K, Baker SJ, Cosenza SC, Basu I, Gupta YK, Reddy MV, Ueno L, Hart JR, Vogt PK, Mulholland D, Guha C, Aggarwal AK, Reddy EP. Choosing to participate in a study is an important personal decision. Epidermolysis bullosa (EB) is a heritable skin disease characterized by marked fragility of epithelialized tissue with blistering in skin and mucous membranes following the slightest mechanical trauma. [ Time Frame: At Baseline, at Week 4, Every 4 Weeks thereafter, and at the End-of-treatment. The following time points will be used to collect samples to determine the AUC on Day 1 and 15: Pre-dose the first dose of the day and at 0.5, 1.0, 1.5, 2.0, 4.0, 6.0, and 8.0 hour post dose the first dose of the day. Found inside – Page 271Rigosertib, another PI3Kα/β inhibitor currently explored for myelodysplastic syndrome, induced apoptosis in CLL cells ... Other PI3Kδ-specific inhibitors are also in preclinical and early clinical trials in CLL, including PWT143 and ... We are studying rigosertib as a new anticancer drug. Note: patients with RAEB-t/non-proliferative AML (as defined by 20-30% BMBL, WBC ≤ 25,000 x 10^9/L and stable for at least 4 weeks without intervention) are not eligible for the Phase II Part 1 RPTD component of the study and patients with CMML will not be eligible for Phase II Part 2 Expansion of the study. Scientific Review.  (Clinical Trial), A Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib With Azacitidine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia, Experimental: Oral rigosertib plus azacitidine, 18 Years and older   (Adult, Older Adult). Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Lancet Oncol. Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. The first two parts have been completed. Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in … Found inside – Page 109Rigosertib, another compound currently in clinical trials, works as an indirect inhibitor of RAS by binding to the RBDs of RAS effectors and preventing interaction with RAS (Athuluri-Divakar et al., 2016). However, recent experimental ... Active infection not adequately responding to appropriate therapy. Read our, ClinicalTrials.gov Identifier: NCT01926587, Interventional This title demonstrates how advanced formulation designs and delivery technologies can be used to improve drug efficacy and treatment outcomes in particular therapeutic categories or disease states. Garcia-Manero G, Fenaux P. Comprehensive Analysis of Safety: Rigosertib in 557 Patients with Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML). Alanine transaminase (ALT)/aspartate transaminase (AST) ≥ 2.5 x upper limit of normal (ULN). Why Should I Register and Submit Results? Choosing to participate in a study is an important personal decision. Patients will receive Physician's Choice of Treatment or alternative treatment which may include any approved or standard-of-care therapy, based on frequently used treatment for MDS (no experimental therapy) + best supportive care. Familial acute myeloid leukemia with mutated CEBPA, Cytogenetically normal acute myeloid leukemia, Core binding factor acute myeloid leukemia, Genetic and Rare Diseases Information Center, Myelodysplastic/myeloproliferative Disease, Information about clinical trials at MD Anderson Cancer Center. Oral rigosertib will be administered twice a day in fasting conditions for weeks 1, 2, and 3 of a 4-week cycle. For AML patients, no more than 1 prior salvage therapy. For general information, Learn About Clinical Studies. 1) inhibitors (such as nivolumab, pembrolizumab, cemiplimab). Children's Assent. The Phase II, Part 2 Expansion will assess if treatment with rigosertib in combination with azacitidine, has measurable effects in patients with myelodysplastic syndrome (MDS). Expert Rev Anticancer Ther. Rigosertib (ON 01910.Na) is an inhibitor of the phosphoinositide 3-kinase and polo-like kinase pathways that induces mitotic arrest and apoptosis in neoplastic cells, while sparing normal cells. The trial will be conducted in two study centres, in London and Salzburg, and will last approximately 2.5 years with each patient recruited being in the study for 1 year. Found inside – Page 501Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced ... Phase I study of Rigosertib, an inhibitor of the phosphatidylinositol 3-kinase and Polo-like kinase 1 pathways, ... Rigosertib is an investigational drug, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) to treat any diseases. Patients will receive best supportive care (BSC): azacitidine (AZA) and/or decitabine (DAC) are permitted. How to Work With Your Health Insurance Plan. Found inside – Page 90RIGOSERTIB Rigosertib is the lead molecule of the company. The drug is being tested in multiple clinical trials, globally. It is being evaluated as a single agent intravenous formulation in a phase III study and as a combination therapy ... Chronic use (˃ 2 weeks) of corticosteroids (˃ 10 mg/24 hr equivalent prednisone) within 4 weeks of Baseline/First Dose. Found inside – Page 4-30Na (now known as rigosertib, and with a planned trade name of EstybonTM ) is a synthetic benzyl styryl sulfone in ... It has reached Phase III clinical trials for the treatment of chronic myelomonocytic leukemia, with the most ... Found inside – Page 67... advanced research (phase II and III clinical trials). These include dactolisib, omipalisib, voxtalisib, apitolisib, bimiralisib, serabelisib, tenalisib, piralalisib, taselisib, rigosertib, and gedatolisib, as well as many others. Navada SC, Silverman LR. Rigosertib was developed by Onconova Therapeutics and is currently tested in several clinical trials for a number of other cancers including myelodysplastic syndrome (a cancer of the blood). Patients received either 140mg rigosertib 2x daily, 280mg 2x daily, or 840mg daily. A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling. Total score is reported (range 0-75; 0 means EB has no affect on ones life, the higher the score the more affect and annoyance/handicap). Rigosertib is not FDA-approved or commercially available. Federal Government Programs. Failure to respond to RDEB SCC standard of care, such as surgical excision, radiotherapy or conventional cytotoxic chemotherapy with e.g. Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening for other rigosertib studies may be screened for participation Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabine [ Time Frame: Up to 30 Months ], Exploratory Objective: Bone Marrow Genomic Mutational Status [ Time Frame: At screening, every 8 week during study treatment, and at the end of study treatment ], Exploratory Objective: Transition to Acute Myelogenous Leukemia (AML) [ Time Frame: Through study completion, an average of 8 months ], Safety Objective: Number of Patients with AEs. tubal occlusion, hysterectomy or bilateral salpingectomy) will not be required to undergo pregnancy test. Psychiatric illness or social situation that would limit the patient's ability to tolerate and/or comply with study requirements. Drug: Rigosertib Oral Capsules / Rigosertib Intravenous. Approximately 360 patients < 82 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DAC for ≤ 9 months and/or ≤ 9 cycles over 12 months and had their last dose of AZA or DAC within 6 months prior to screening will be stratified by: Patients will be treated until 2006 IWG progression criteria are met (ie, 50% increase of BM blasts or worsening of cytopenias) or until an unacceptable toxicity or intolerance. Uncontrolled hypertension. This pilot trial studies how rigsertib sodium works in treating patients with Recessive Dystrophic Epidermolysis bullosa (RDEB) with locally advanced Squamous Cell Carcinoma (SCC). Found inside – Page 353Table 20.1 Targeted therapies in HNSCC Type of drug Drug Target Stage of development NCT number Adenovirus gene ... Concurrent with these studies, early-phase clinical trials were initiated to explore the combination of radiation and ... Listing a study does not mean it has been evaluated by the U.S. Federal Government. Responses of complete remission (CR), partial remission (PR), mCR, SD, failure, and PD will be determined by 2006 IWG criteria. In light of scarce data on the efficacy and safety of systemic treatment regimens for advanced SCC, the investigators propose to perform a small, "first in EB " trial of an experimental drug called rigosertib for the treatment of EB cancer. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Known hypersensitivity reaction to any of the components of study treatment. Than MDS, CMML, or PD will be enrolled at French site to... Rigosertib most selectively kills EB cancer cells in vitro while leaving normal EB skin cells unaffected learn if rigosertib help. A drop in the treatment of MDS: Up to 30 months ]...... 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