Protocol Title. A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer [*]
Protocol Title. A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Post-menopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer Company: Syndax Pharmaceuticals, Inc. *** *** INDICATES EIGHT PAGES OF MATERIAL THAT WERE OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. EXHIBIT B E2112 Budget & Payment Schedule
Protocol Title. A Phase II Study of Humanized Monoclonal Antibody 3F8 (Hu3F8) with Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma (attached hereto as Attachment 1) This Appendix A — Study Addendum (“Study Addendum”) is effective as of the date of the last party to sign (“Addendum Effective Date”), by and between Y-mAbs Therapeutics, Inc. a corporation with offices at 000 Xxxxx Xxxxxx, 0xx xxxxx, Xxx Xxxx, XX 00000 (“Company”), on the one hand; and MEMORIAL SLOAN KETTERING CANCER CENTER, a New York not-for-profit corporation with principal offices at 0000 Xxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000, on behalf of Memorial Hospital for Cancer and Allied Diseases, its Regional Network sites, MSK Alliance Clinical Trial Sites, and its Cancer Health Equity Research Program Sites (“MSK”), and on behalf of itself and the Investigator referenced herein on the other hand.
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Every environmental incident (e.g. leakage of fuel, lubricants or coolants) must be reported immediately to the CO.
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Clinical Research Protocol Title: Dapagliflozin Augments The Favorable Adaptation To Endurance Exercise TrainingBiomedical 11/01/201811/06/2018-11/05/2019This Print View may not reflect all comments and contingencies for approval.
Protocol Title Study Depart Study Director Phone # Study start date Approx lgth of study Dept providing Service: Department location: Estimated # of pts to be seen: 1.2.3.4.5.6.7.Service or ItemEst.
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Protocol Title. One multicenter, randomized, open, phase III clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of metastatic hormone-sensitive prostate cancer with high tumor load” Název Protokolu: „Multicentrické, randomizované, otevřené klinické hodnocení fáze III porovnávající přípravek SHR3680 v kombinaci s androgen deprivační terapií (ADT) oproti bikalutamidu v kombinaci s ADT při léčbě metastazujícího hormonálně senzitivního karcinomu prostaty s vysokou nádorovou zátěží“ Protocol Date: December 5, 2018 Datum Protokolu: 5. prosince 2018 Sponsor: Jiangsu Hengrui Medicine Co., Ltd. Zadavatel: Jiangsu Hengrui Medicine Co., Ltd. Country where Site is Conducting Study: Czech Republic Stát, ve kterém má sídlo Místo provádění klinického hodnocení, které provádí Studii: Česká republika Location where the study will be conducted: Department of Clinical Oncology, which is a division/part of the Institution Místo, kde bude prováděna Studie: Oddělení klinické onkologie, které je součástí/oddělením Zdravotnického zařízení Key Enrollment Date: 100 Calendar Days after Site Initiation Visit (being the date by which Site must enrol at least one (1) subject as more specifically set out in section 1.7 “Key Enrollment Date” below) Klíčové datum zařazení: 100 kalendářních dnů po Iniciační návštěvě Místa provádění klinického hodnocení (a to jakožto den, ke kterému je Místo provádění klinického hodnocení povinno zařadit minimálně jeden (1) subjekt, jak je dále podrobněji rozvedeno níže v odstavci 1.7 „Klíčové datum zařazení“) ECMT / EC / RA: ECMT: Etická komise FN Olomouc, I. P. Xxxxxxx 000/0, 000 00 Xxxxxxx, Xxxxx Xxxxxxxx EC: Etická komise Nemocnice Na Homolce, Xxxxxxxxxxx 0, 000 00 Xxxxx 0, Xxxxx Xxxxxxxx RA: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00, Xxxxx Xxxxxxxx MEK / EK / SÚKL: MEK: Etická komise FN Olomouc, I. P. Xxxxxxx 000/0, 000 00 Xxxxxxx, Xxxxx xxxxxxxxx LEK: Etická komise Nemocnice Na Homolce, Roentgenova 2, 150 30 Xxxxx 0, Xxxxx xxxxxxxxx SÚKL: Státní ústav pro kontrolu léčiv, Šrobárova 48, 100 41 Xxxxx 00, Xxxxx xxxxxxxxx The following additional definitions shall apply to this Agreement: Ve Smlouvě jsou použity následující smluvní definice: Protocol: the clinical protocol referenced above as it may be modified from time to time by the Sponsor (defined below). Protokol: klinický protokol, na který je odkázáno výše, a který může podléhat čas od času změnám provedeným Zadavatelem (v...
Protocol Title. A Placebo-controlled, double-blind, Randomized, dose-finding phase II study on OMT-28 in Maintenance of Sinus rhythm after Electrical cardioversion in patients with persistent Atrial Fibrillation (PROMISE-AF) as amended from time to time and incorporated herein by reference (hereinafter referred to as the “Protocol”) Protocol Number: OMT28-C0201 Covance wishes to engage and Institution desires to participate in conducting the Study;
Protocol Title. A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose- finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to- severe ulcerative colitis as amended from time to time and incorporated herein by reference (hereinafter referred to as the “Protocol”) Protocol Number: P2-IMU-838-UC Whereas, Investigator, an employee of Institution, has the knowledge and experience to undertake the Study and , klinika VFN a 1. LF UK, U Nemocnice 499/2, 128 08 Xxxxx 0, Xxxxx xxxxxxxxx, (dále jen "Zkoušející") Jelikož, jsou společnost Xxxxxxxx, Zdravotnické zařízení a Zkoušející zde dále označováni jednotlivě jako „Strana“ a společně jako „Strany“; Jelikož, společnost Xxxxxxxx jako smluvní výzkumná organizace, jak je definována ve směrnici ICH-GCP 1.20, jedná jako nezávislý dodavatel subjektu Immunic AG, Am Klopferspitz 19, 82152 Planegg-Martinsried, Německo (dále jen "Zadavatel"), s cílem spolupracovat se Zadavatelem při provádění níže uvedené výzkumné klinické studie (dále jen "Studie") popsané níže: Studijní lék: (dale jen “Studijní lék”) Název protokolu: Multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie fáze 2 zaměřená na zjištění dávky, hodnotící účinnost a bezpečnost přípravku IMU-838 pro indukční a udržovací léčbu x xxxxxxx xxxxxxx xx xxxxxxx ulcerózní kolitidy, jak vyplývá z pozdějších změn, doplnění a úprav, a uváděném zde odkazem (dale jen “Protokol”) Číslo protokolu: P2-IMU-838-UC Jelikož, Zkoušející, zaměstnanec Zdravotnického zařízení, má znalosti a zkušenosti k provedení Studie a společnost Xxxxxxxx wishes to engage Institution and Investigator to conduct the Study Whereas, Institution and Investigator desire to participate in conducting the Study; Now, therefore, the Parties hereto agree as follows:
Protocol Title. A Phase III Study of BBI-608 plus nab- Paclitaxel with Gemcitabine in Adult Patients with Metastatic Pancreatic Adenocarcinoma” as amended from time to time and incorporated herein by reference (hereinafter referred to as the “Protocol”) Protocol Number: CanStem111P Studijní lék: BBI-608 (neboli BBI608, ), (xxxx xxx “Studijní lék”) Název protokolu: „Studie přípravku BBI-608 fáze III plus nab-Paclitaxel s gemcitabinem u dospělých pacientů s metastatickým adenokarcinomem slinivky břišní“jak vyplývá z pozdějších změn, doplnění a úprav, a uváděném zde odkazem (xxxx xxx “Protokol”) Xxxxx protokolu: CanStem111P referred to as “Investigator”) will conduct the Clinical Trial at the Institution under terms and conditions separately agreed between Chiltern and Investigator. Wherever, in this Agreement, reference is made to obligations, which are incumbent on the Investigator, such reference is intended for the purpose of informing the parties to this Agreement accordingly.
Protocol Title. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women with Irritable Bowel Syndrome Protocol Number: URO-901-2001 Brief Title: Double-blind, Placebo-controlled Study of Vibegron in Irritable Bowel Syndrome Study Rationale: Animal models have shown that beta-3 adrenergic receptor (β3-AR) activation protects against gastric ulcers, inhibits castor-oil induced diarrhea, and reduces observed pain behavior [Vasina, 2008; Xxxxxx, 2007]. Clinical studies of solabegron, a β3-AR agonist, have shown improvement in pain among women with IBS, with no effect on gut motility in healthy subjects [Xxxxxxx, 2008; Xxxxxxxx, 2008]. Vibegron, a novel β3-AR agonist, is in clinical development for the treatment of overactive bladder. It has been studied in approximately 2300 subjects (1840 with overactive bladder and 460 healthy subjects) and is currently being assessed in Phase 3 studies. All clinical data available to date indicate that vibegron is well tolerated. Objectives and Endpoints (Primary and Secondary Only): The primary study objective is to compare the effect of vibegron vs placebo in subjects with abdominal pain due to irritable bowel syndrome (IBS) with predominantly diarrhea (IBS-D) on the abdominal pain intensity (API) weekly responder rate over 12 weeks. Secondary objectives are to: • Compare the effect of vibegron vs placebo in subjects with abdominal pain due to IBS-D or mixed episodes of diarrhea and constipation (IBS-M) on patient-reported outcomes • Compare the effect of vibegron vs placebo in subjects with abdominal pain due to IBS-D on the API weekly responder rate over 12 weeks based on different thresholds of improvement • Compare the effect of vibegron vs placebo in subjects with abdominal pain due to IBS-D or IBS-M on safety endpoints The primary endpoint is the proportion of API weekly responders over 12 weeks, with an API Weekly Responder defined as a subject who experiences a decrease in the weekly average of “worst abdominal pain in the past 24 hours” scores of at least 30% compared with the baseline weekly average. Secondary endpoints are the proportion of Global Improvement Scale responders at Week 12, the proportion of IBS-D subjects who are API weekly responders with at least 40% improvement over 12 weeks, the proportion of IBS-D subjects who are API responders with at least 50% improvement over 12 weeks, adverse events (AEs), clinical laborator...
Protocol Title. A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCV AC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer eligible for I" line chemotherapy as amended from time to time and incorporated herein rezistentním karcinomem prostaty indikovaným k chemoterapii první linie úplné znění, jak vyplývá z pozdějších změn, doplnění a úprav, a uváděném zde odkazem (dále jen „Protokol“) by reference (hereinafter referred to as the “Protocol”)
Protocol Title. “ ” as amended from time to time and incorporated herein by reference (hereinafter referred to as the “Protocol”) Protocol Number: Hodnocený přípravek: (xxxx xxx „Hodnocený přípravek“) Název protokolu: „ “ v čas od času doplňovaném znění, který je do této smlouvy začleněn odkazem (xxxx xxx „Protokol“) Xxxxx protokolu: