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.
Examples of Protocol Title in a sentence
Protocol Number: RPC01-3102 Číslo Protokolu: RPC01-3102 Protocol Title: A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis Název Protokolu: Multicentrické nezaslepené pokračovací klinické hodnocení fáze 3 perorálně podávaného přípravku RCP1063 k léčbě středně těžké až těžké ulcerózní kolitidy Protocol Date: 08 May 2015 Datum Protokolu: 8.
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Protocol Title. „ ” Název protokolu: :„
Protocol Title. A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2) Název Protokolu: 24-týdenní, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze III s paralelními rameny posuzující účinnost a bezpečnost přípravku BLU-5937 s otevřenou pokračovací fází u dospělých účastníků s refrakterním chronickým kašlem včetně nevysvětlitelného chronického kašle (CALM-2)./ Protocol Date: 21 July 2022 Datum Protokolu: 21. Července 2022 Sponsor: Bellus Health Cough, Inc. Zadavatel: Bellus Health Cough, Inc. 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: Klinika nemocí plicních a tuberkulózy, which is a division/part of the Institution Místo, kde bude prováděna Studie: Klinika nemocí plicních a tuberkulózy, která je součástí/oddělením Zdravotnického zařízení Key Enrolment Date: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Klíčové datum zařazení: xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ECMT / EC / RA CEC/LEC: Fakultní nemocnice Brno, Xxxxxxxxx 00, 000 00 Xxxx, Xxxxx xxxxxxxxx RA: Státní ústav pro kontrolu léčiv, Xxxxxxxxx 00, 000 00 Xxxxx 00, Xxxxx Xxxxxxxx MEK / EK / SÚKL MEK / LEK : Fakultní nemocnice Brno, Jihlavská 20, 625 00 Brno, Česká republika SÚKL: Státní ústav pro kontrolu léčiv, Xxxxxxxxx 00, 000 00 Xxxxx 00, Xxxxx republika 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 (ve smyslu níže uvedené definice) Case Report Form or CRF: case report form (paper or electronic) to be used by Site to record all of the Protocol-required inform...
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 Now, therefore, the Parties hereto agree as follows: Nyní proto zde strany dohodly následující:
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 Double-Blind, Randomized, Placebo-Controlled Study Of The Safety And Efficacy Of Three Dose Regimens Of Oral Aliminase In The Treatment Of Active Ulcerative Colitis Protocol No. 9084 Study Specifications Protocol Number 9084 Carrington Contact Kenneth (Bill) Yates, D.V.M. XXX Xxarmaco Contact Xxxty Xxxlex, Xxrector, Business Development Xxxxxxnd Aliminase Indication Active Ulcerative Colitis Program Phase II Study Design Double-Blind, Randomized, Placebo- Controlled, Safety & Efficacy Study Number of Screened Patients 350 Number of Enrolled Patients 280 Number of Completed Patients 280 Number of Investigators 40 Investigators Meeting Yes, 94 attending Approximate Number of Qualification Visits 40 Type of IRB Local & Central Number of Initiation Visits 40 Approximate Number Patients Per Site 9 Enrollment Period 7.7 Months Enrollment Rate .9 Patients/Month Duration of Patient Participation 1.5 Months Interim Monitoring Frequency Q6-8 Weeks Number of Interim Visits (excluding closeout visits) 7 Per Site (280 total) Number of Close Out Visits 40 Estimated Number of Case Report Form (CRF) Pages Per Patient 26 Estimated Number of Unique Pages Per CRF 16 Estimated Number of CRF Pages for Data Entry 7,280 Number of Statistical Tables 38 Number of Statistical Listings 26 Number of Statistical Figures 2 Deliverable Clinical Statistical Report PROJECT TIMELINES Project Milestone Periods The program timeline is summarized in the table below. Activity Study Initiation Jan. 1, 1999 - Mar. 30, 1999 Investigator Meeting February 1999 Enrollment Period * Mar. 31, 1999 - Nov. 25, 1999 Treatment Period Mar. 31, 1999 - Jan. 10, 1999 Study Closeout Jan. 11, 1999 - Feb. 10, 2000 Biostatistics Feb. 11, 2000 - Mar. 25, 2000 Clinical Statistical Report Mar. 26, 1999 - May 5, 2000 Total PPD Pharmaco Commitment -16.2 Months * Any extension to the enrollment period will result in contract modifications. STATEMENT OF SERVICES The following lists the specific responsibilities assigned to Carrington () or PPD Pharmaco ().
Protocol Title. A Double-Blinded, Placebo-controlled, Double Dummy, Multi-center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One, Two or Three Oral Glucose-lowering Agents. Pursuant to 21 CFR 312.52 and ICH E6, the following obligation(s) of the Sponsor, Oramed Ltd. have been transferred to: CRO Name: Integrium, LLC CRO Address: 00000 Xxxxxx Xxxx Xxxxxx, XX 00000 Obligation Assigned to:1
Protocol Title. A Four-Period, Four-Treatment, Four-Sequence Randomized Crossover Study of the Comparative Bioavailability of Metoclopramide After Nasal and Oral Administration to Healthy Volunteers Under Fasted Conditions ∎ ∎ ∎ ∎ ∎ ∎ [name(s)] ∎ ∎ ∎ ∎ ∎ ∎ Submitted by: Xxxxx Xxxxx ∎ Director, Business Development ∎ Xxxxxxxxx Clinical Research, LLC ∎ 000 X. Xxxxxxxxxxx Xxxxx ∎ Xxxx Xxxx, Xxxxxxxxx 00000 ∎ Tel: 000-000-0000 ∎ Email: Xxxxx.Xxxxx@xxxxxxxxxxxxxxxxx.xxx ∎ ∎ Date Submitted: 13 April 2017 ∎ ∎ ∎