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phase i study of single

  • Description:Phase I study of single-agent anti-programmed death-1 …This phase I study sought to determine the safety and tolerability of anti-PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity, pharmacodynamics, and immunologic correlates.Cited by 2564Publish Year 2010Author Julie R. ...
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phase i study of single Description

A Phase I Study of Single Administration of Antibody phase i study of single

Purpose Antibody-directed enzyme prodrug therapy is a two-stage treatment whereby a tumor-targeted antibody-enzyme complex localizes in tumor for selective conversion of prodrug. The purpose of this study was to establish optimal variables for single administration of MFECP1, a recombinant antibody-enzyme fusion protein of an anticarcinoembryonic antigen single-chain Fv antibody and the phase i study of singleA Phase I Study of Single-Agent Nilotinib (AMN107) or in phase i study of singleSep 15, 2009Study design. In this open-label, Phase I, dose-escalation study, patients were assigned sequentially either to (1) single-agent nilotinib 400 mg bid (the dose currently recommended for hematological malignancies) ; or (2) inter-cohort escalating doses of nilotinib (200 mg qd, 400 mg qd or 400 mg bid) in combination with imatinib 400 mg bid phase i study of singleA Single-Center, Phase I Clinical Study to Evaluate the phase i study of singleSep 24, 2020A Single-Center, Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

A phase I ascending single-dose study of the safety phase i study of single

A phase I ascending single-dose study of the safety, tolerability, and pharmacokinetics of bosutinib (SKI-606) in healthy adult subjects Cancer Chemother Pharmacol . 2012 Jan;69(1):221-7. doi 10.1007/s00280-011-1688-7.A phase I study to assess the effect of food on the single phase i study of singleA phase I study to assess the effect of food on the single dose bioavailability of the THC/CBD oromucosal spray Eur J Clin Pharmacol . 2013 Apr;69(4):825-34. doi 10.1007/s00228-012-1393-4.A phase I, randomized, single-dose pharmacokinetic study phase i study of singleSep 19, 2020Study design. This was a double-blind, single-dose, three-arm, and parallel-group study performed at a single center in Belgium between April 2015 and September 2015 (clinicaltrials.gov identifier NCT02453672; EudraCT number 2015-001,026-41). The final study protocol was approved by the Independent Ethics Committee (IEC) of Belgium.

Cited by 14Publish Year 2020Author Jonathan Rosenberg, Srikala S Sridhar, Jingsong Zhang, David Smith, Dean Ruether, Thomas W Flaig, Jo phase i study of singleAZD1775 for Advanced Solid Tumors - Full Text View phase i study of single

Dec 13, 2012A Phase I Study of Single-agent AZD1775 (MK-1775), a Wee1 Inhibitor, in Patients With Advanced Refractory Solid Tumors Actual Study Start Date December 19, 2012 Actual Primary Completion Date May 19, 2020 Actual Study Completion Date May 19, 2020Cited by 14Publish Year 2020Author Jonathan Rosenberg, Srikala S Sridhar, Jingsong Zhang, David Smith, Dean Ruether, Thomas W Flaig, Jo phase i study of singleOfficial Protocol Title Phase I Study of Single Agent phase i study of single1.1 TITLE Phase I Study of Single AgentPembrolizumab(MK-3475)in Patients with Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma.(KEYNOTE 001) 1.2 INDICATION For PartA, patients with a histologically or cytologically confirmed diagnosis of any type of carcinoma or of melanoma (MEL) who have progressive locally Cited by 2564Publish Year 2010Author Julie R. Brahmer, Charles G. Drake, Ira Wollner, John D. Powderly, Joel Picus, William H. Sharfman, phase i study of singleEV-101 A Phase I Study of Single-Agent Enfortumab Vedotin phase i study of singleA pivotal phase II and a confirmatory phase III study are ongoing. EV-101 A Phase I Study of Single-Agent Enfortumab Vedotin in Patients With Nectin-4-Positive Solid Tumors, Including Metastatic Urothelial Carcinoma J Clin Oncol. 2020 Apr 1;38(10) :1041-1049. phase i study of single

Cited by 2564Publish Year 2010Author Julie R. Brahmer, Charles G. Drake, Ira Wollner, John D. Powderly, Joel Picus, William H. Sharfman, phase i study of singlePhase I Study of Single-Agent AntiProgrammed Death-1

Jun 01, 2010This phase I study sought to determine the safety and tolerability of antiPD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity, pharmacodynamics, and immunologic correlates.Clinical Pharmacology 1 Phase 1 studies and early drug phase i study of singleADME (i.e. Mass Balance) Study* Objective To understand the full clearance mechanisms of the drug and its metabolites in humans Typically single dose, healthy males (n=4-6), atClinical Trial Phases What Happens in Phase 0, I, II, III phase i study of singleJun 21, 2019Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.

EV-101 A Phase I Study of Single-Agent Enfortumab

Feb 07, 2020Because of the strength of these data, single-agent EV has been investigated in patients with locally advanced/mUC previously treated with antiPD-(L)1 therapy in a pivotal phase II study (EV-201; ClinicalTrials.gov identifier NCT03219333) 15 and is currently enrolling a confirmatory randomized phase III study (EV-301; ClinicalTrials.gov phase i study of singleEV-101 A Phase I Study of Single-Agent Enfortumab Vedotin phase i study of singleFeb 07, 2020This phase I, dose escalation/dose expansion study of EV, a Nectin-4targeted ADC, identified 1.25 mg/kg administered on days 1, 8, and 15 of a 28-day cycle as the RP2D on the basis of the dose at which EV was active and generally well tolerated.J&J kicks off study of single-shot COVID-19 vaccine in phase i study of singleIn August, J&J signed an agreement with the British government on a global Phase III clinical trial to study a two-dose version of its vaccine, which will run in parallel with the single-dose trial.

P1-12-19 Phase I Study of Single Agent Trastuzumab phase i study of single

Methods This Japanese Phase I study was a single-arm, dose-escalation study in patients with HER2positive MBC who had received prior therapies that included trastuzumab. The objective of the study was to determine the MTD of T-DM1 during Cycle 1, using the continual reassessment method, among three dose cohorts when administered as a single phase i study of singlePATRIOT A phase I study to assess the tolerability phase i study of singleAug 01, 2018PATRIOT A phase I study to assess the tolerability, safety and biological effects of a specific ataxia telangiectasia and Rad3-related (ATR) inhibitor (AZD6738) as a single agent and in combination with palliative radiation therapy in patients with solid tumoursPHASE I/II CLINICAL TRIAL DESIGN AND DOSE FINDING study with a narrower dose range study Use pharmacological response or biological markers from animal studies and phase I studies to guide the selection in dose range for the early studies Although not always attainable in early studies, a goal should be to try and define the Maximally Tolerated Dose (MTD), the Maximally

PHASE I/II CLINICAL TRIAL DESIGN AND DOSE FINDING

study with a narrower dose range study Use pharmacological response or biological markers from animal studies and phase I studies to guide the selection in dose range for the early studies Although not always attainable in early studies, a goal should be to try and define the Maximally Tolerated Dose (MTD), the MaximallyPharmacokinetics and Safety of Single and Multiple Doses phase i study of singleNov 04, 2020Few studies have evaluated whether the pharmacokinetics of N-acetyl-cysteine (NAC) are different in Chinese and Caucasian individuals. This single- and multiple-dose, single-centre, open-label, phase I clinical study was conducted in healthy adult volunteers. All participants received oral NAC 600-mg uncoated tablets, which were administered first as a single dose and, following a 48-h wash phase i study of singlePhase 1 Clinical PK Study, Part 1 Study DesignMay 13, 2014This is a Phase 1, single-ascending dose (SAD), placebo-controlled, double-blind, clinical study to evaluate the pharmacokinetics, safety, and tolerability of drug X in healthy volunteers. Subjects will be enrolled into escalating dose cohorts (N=X) and randomly assigned in a 3:1 ratio to receive either Drug X (n=X) or placebo (n=X) at one of phase i study of single

Phase I Study of 30-Minute Infusion of Carfilzomib As phase i study of single

Sep 15, 2014Purpose Carfilzomib is an irreversible inhibitor of the constitutive proteasome and immunoproteasome. This phase I study evaluated the maximum-tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of carfilzomib administered as a 30-minute intravenous (IV) infusion. Safety and efficacy of carfilzomib as a single agent or in combination with low-dose Phase I Study of Single-Agent AZD1775 (MK-1775), a Wee1 phase i study of singleMay 11, 2015Purpose Wee1 tyrosine kinase phosphorylates and inactivates cyclin-dependent kinase (Cdk) 1/2 in response to DNA damage. AZD1775 is a first-in-class inhibitor of Wee1 kinase with single-agent antitumor activity in preclinical models. We conducted a phase I study of single-agent AZD1775 in adult patients with refractory solid tumors to determine its maximum-tolerated dose (MTD phase i study of singlePhase I Study of Single-Agent AZD1775 (MK-1775), a Wee1 phase i study of singleMay 11, 2015Purpose Wee1 tyrosine kinase phosphorylates and inactivates cyclin-dependent kinase (Cdk) 1/2 in response to DNA damage. AZD1775 is a first-in-class inhibitor of Wee1 kinase with single-agent antitumor activity in preclinical models. We conducted a phase I study of single-agent AZD1775 in adult patients with refractory solid tumors to determine its maximum-tolerated dose (MTD phase i study of single

Phase I Study of Single-Agent Utomilumab (PF

Cancer Therapy Clinical Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer Neil H. Segal1, Aiwu R.He2,Toshihiko Doi3, Ronald Levy4, Shailender Bhatia5, Michael J. Pishvaian2, Rossano Cesari6,Ying Chen7, Craig B. Davis7, Bo Huang8, Aron D.Thall7, and Ajay K. Gopal5 AbstractPhase I Study of Single-Agent Utomilumab (PF Cancer Therapy Clinical Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer Neil H. Segal1, Aiwu R.He2,Toshihiko Doi3, Ronald Levy4, Shailender Bhatia5, Michael J. Pishvaian2, Rossano Cesari6,Ying Chen7, Craig B. Davis7, Bo Huang8, Aron D.Thall7, and Ajay K. Gopal5 AbstractPhase I Study of Single-Agent Utomilumab (PF-05082566), a phase i study of singlePhase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer Neil H. Segal, Aiwu R. He, Toshihiko Doi, Ronald Levy, Shailender Bhatia, Michael J. Pishvaian, Rossano Cesari, Ying Chen, Craig B. Davis, Bo Huang, Aron D. Thall and Ajay K. Gopal DOI 10.1158/1078-0432.CCR-17-1922 Published April 2018

Phase I study of single-agent anti-programmed death-1

This phase I study sought to determine the safety and tolerability of anti-PD-1 blockade in patients with treatment-refractory solid tumors and to preliminarily assess antitumor activity, pharmacodynamics, and immunologic correlates.Phase I study of single-dose pharmacokinetics and phase i study of singleThis phase I trial examined the pharmacokinetics and pharmacodynamics (percentage CD86 receptor occupancy [%CD86RO]) of a single dose of belatacept (7.5 mg/kg) administered to kidney transplant recipients aged 12-17 years receiving a stable calcineurin inhibitor-based immunosuppressive regimen.Phase I study of single-dose pharmacokinetics and phase i study of singleThis phase I trial examined the pharmacokinetics and pharmacodynamics (percentage CD86 receptor occupancy [%CD86RO]) of a single dose of belatacept (7.5 mg/kg) administered to kidney transplant recipients aged 12-17 years receiving a stable calcineurin inhibitor-based immunosuppressive regimen.

Phase I study of singleagent ribociclib in Japanese phase i study of single

2.1. Study design and treatment. In this phase I, multicenter, singlearm, openlabel study, Japanese patients with Rb+ advanced solid tumors were treated with singleagent ribociclib. Patients Rb+ status was determined by testing of tumor samples by molecular screening at a Phase I study of singleagent ribociclib in Japanese phase i study of single2.1. Study design and treatment. In this phase I, multicenter, singlearm, openlabel study, Japanese patients with Rb+ advanced solid tumors were treated with singleagent ribociclib. Patients Rb+ status was determined by testing of tumor samples by molecular screening at a SAD Phase I Study (First-in-human) to Investigate phase i study of singleThe investigation on the compound Contraloid acetate in a single-ascending-dose phase I study (first-in-human) has been performed in 40 healthy male participants, randomly assigned to the treatment. Main focus was on the evaluation of the outcome of the safety and tolerability; secondarily the pharmacokinetic characteristics of the compound phase i study of single

Safety, tolerability, and pharmacokinetics of a single phase i study of single

DESIGN Single-center, open-label, randomized Phase I study. METHODS Twelve healthy male subjects received a single s.c. dose of pasireotide 300 g followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).Safety, tolerability, and pharmacokinetics of a single phase i study of singleDESIGN Single-center, open-label, randomized Phase I study. METHODS Twelve healthy male subjects received a single s.c. dose of pasireotide 300 g followed by a washout period of 7 days (or at least 5 days), before receiving an i.m. injection of pasireotide -LAR 40 mg (n=5) or 60 mg (n=7).Single Ascending Dose & Multiple Ascending DoseMay 03, 2016The Phase I trials are generally conducted in the following sequence single ascending dose, multiple ascending dose, examination of preliminary effect

phase i study of single

phase i study designsingle phase and three phasesingle phase to 3 phasephase i study definitionphase i study sample sizesingle phase and 3 phase explainedsingle phase vs 3 phasestudy phases of drugsPhase I study of single-dose pharmacokinetics and phase i study of singleThis phase I trial examined the pharmacokinetics and pharmacodynamics (percentage CD86 receptor occupancy [%CD86RO]) of a single dose of belatacept (7.5 mg/kg) administered to kidney transplant recipients aged 12-17 years receiving a stable calcineurin inhibitor-based immunosuppressive regimen.phase i study of singlephase i study designsingle phase and three phasesingle phase to 3 phasephase i study definitionphase i study sample sizesingle phase and 3 phase explainedsingle phase vs 3 phasestudy phases of drugsSome results are removed in response to a notice of local law requirement. For more information, please see here.phase i study of singlephase i study designsingle phase and three phasesingle phase to 3 phasephase i study definitionphase i study sample sizesingle phase and 3 phase explainedsingle phase vs 3 phasestudy phases of drugsSome results are removed in response to a notice of local law requirement. For more information, please see here.Phase I Study of Single-Agent AntiProgrammed Death-1 Jun 01, 2010This multi-institutional, first in-human, open-label, phase I, dose-escalation study was approved by local institutional review boards. All participating patients signed informed consent. The primary objectives were to characterize the safety and tolerability of a single dose of MDX-1106 in patients with selected malignancies and to determine phase i study of single

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