Phase II Clinical Trials
Minimax and admissible adaptive two-stage designs in phase II clinical trials
... In phase II clinical trials, it is desirable to achieve the primary goal of the study with the number of patients minimized, as the cost of the study highly depends on the number of ...and ...
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Optimal Two-stage designs in Phase-II Clinical Trials.
... Multi-stage or group-sequential designs are especially useful for this purpose. In a multi-stage design, the observed response rate is computed on accumulating data from patients entering the study sequentially at ...
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Promising investigational drug candidates in phase I and phase II clinical trials for mesothelioma
... A phase I trial of SS1P (which exerts its effects via targeting of mesothelin and Pseudomonas exotoxin A) aimed to verify the side effects and best dose of this immunotoxin approach in treating patients with ...
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Dose-finding designs for Phase II clinical trials
... Estimating the doses of interest with high precision in proof-of-concept studies is vital for the future development of the drug. The goal of a proof-of-concept study is usually to find the lowest dose with a certain ...
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The elements of life and medicines
... In vertebrates, particularly humans, V IV and V V are likely to predominate and the similarity between V V as vanadate and phosphate is likely to be central to its biological effects. Vanadate- dependent haloperoxidases ...
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Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors
... following clinical studies is as follows: anlotinib monotherapy, 12 mg per day, on the 2/1 ...in phase I study, a series of phase II clinical trials have been performed and ...
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Hepatic profile analyses of tipranavir in Phase II and III clinical trials
... many clinical trials are limitations in captur- ing all of the necessary risk factors associated with the out- come being ...these trials was on efficacy in a cohort of patients with highly advanced ...
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Conditionally unbiased estimation in phase II/III clinical trials with early stopping for futility
... in clinical trial design have led to the availability of new approaches referred to as adaptive seamless designs ...a clinical trial is conducted in 2 or more stages with interim analyses performed before ...
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Incidence and risk of severe infections associated with anti-epidermal growth factor receptor monoclonal antibodies in cancer patients: a systematic review and meta-analysis
... controlled phase II and III trials evaluating approved anti-EGFR-MoAbs (cetuximab and panitumumab) in cancer patients with adequate data on severe or fatal infections were incorporated in the ...
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<p>Evaluating the Safety and Efficacy of Nivolumab in Patients with Advanced Hepatocellular Carcinoma: Evidence to Date</p>
... in Phase I/II clinical trials, a Phase III clinical trial that evaluated the role of pembroli- zumab (KEYNOTE-240) in advanced HCC patients who had prior exposure to sorafenib in ...
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Infliximab in the treatment of plaque type psoriasis
... in these studies infliximab treatment was shown to be generally well tolerated and resulted in a rapid and signifi cant improvement in psoriatic signs and symptoms from baseline. Inclusion and exclusion criteria adopted ...
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Profile of netupitant/palonosetron (NEPA) fixed dose combination and its potential in the treatment of chemotherapy-induced nausea and vomiting (CINV)
... in Phase II and Phase III clinical trials for the prevention of CINV in patients receiving moderately and highly emetogenic chemotherapy (MEC and ...The clinical trials ...
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Telavancin, a new lipoglycopeptide antimicrobial, in complicated skin and soft tissue infections
... aureus. Phase II and III clinical trials for complicated skin and skin structure infections have shown telavancin to have similar efficacy and tolerability to that of vancomycin and standard ...
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Dose selection in seamless phase II/III clinical trials based on efficacy and toxicity
... a clinical trial. Trials which combine phase II and phase III into a single trial with a phase II stage and phase III stage are referred to as (seamless) ...
152
A network meta-analysis: the overall and progression-free survival of glioma patients treated by different chemotherapeutic interventions combined with radiation therapy (RT)
... control trials, or clinical trials in phase II or III with more than 30 subjects; (ii) all the subjects were adults who were diagnosed with glioma, irrespective of different ...
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Comparisons of therapeutic efficacy and safety of ipilimumab plus GM-CSF versus ipilimumab alone in patients with cancer: a meta-analysis of outcomes
... prospective Phase I, II, and III clinical trials and expanded-access (ie, outside clinical trials) programs; 2) clinical investigations in patients with cancers (melanoma, ...
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Risk of severe hematologic toxicities in cancer patients treated with PARP inhibitors: a meta-analysis of randomized controlled trials
... these trials, likely drove the severity of the cytopenias, thereby diminishing the difference in severity of cytopenias among the treatment ...combination trials with chemotherapy, the mechanism is unclear ...
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Translation of academic medicinal products towards clinical practice
... proper clinical trial design is essential for reaching the end goals as defined in the ...or clinical trial will be serving the end goal as defined in the ...controlled trials with ATMPs because of ...
192
<p>PARP Inhibitors in Endometrial Cancer: Current Status and Perspectives</p>
... several clinical trials showed that PARP inhibitors have a bene fi cial role in cancers with a defect in the homologous DNA recombination system, regardless of the BRCA mutational ...ongoing trials, ...
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United States experience of insulin Degludec alone or in combination for type 1 and type 2 diabetes
... 1 trials, the estimated ratio was ...the clinical reviewer, disputed the interpretability of hypoglycemia claims, calling into question the definition of confirmed hypoglycemia offered by Novo Nordisk, ...
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