phase II/III clinical trials
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 ...
152
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 ...
19
PubMedCentral-PMC4988831.pdf
... profile, clinical trials have shown that a lower starting capecitabine dose is comparable in efficacy to the approved dose despite the lack of a randomized trial comparing the two ...Randomized phase ...
15
Hepatic profile analyses of tipranavir in Phase II and III clinical trials
... Complete clinical profiles (all laboratory and reported AEs from baseline throughout the participation of the patient in the study) were created and underwent medical ...associated clinical AEs ...
11
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 ...
9
Genotypic Changes in Human Immunodeficiency Virus Type 1 Protease Associated with Reduced Susceptibility and Virologic Response to the Protease Inhibitor Tipranavir
... 105 clinical HIV-1 isolates from patients with prior exposure to other PIs demonstrated that tipranavir retains activity against more than 90% of isolates resistant to other PIs ...A phase II ...
8
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 MEC and ...The clinical trials dem- onstrated that NEPA (300 mg of ...
7
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 ...
12
Use of granisetron transdermal system in the prevention of chemotherapy-induced nausea and vomiting: a review
... unpublished clinical trials (phase II/III) have been conducted to evaluate the antiemetic efficacy of transdermal granisetron in chemotherapy-induced nausea and vomiting, in patients ...
12
Meta analysis of randomized phase II trials to inform subsequent phase III decisions
... of Phase II randomized trials, as motivated by a real example in acute myocar- dial infarction ...how Phase II meta-analysis results can be used to predict the potential intervention ...
15
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 ...
12
The elements of life and medicines
... in phase II clinical trials for treatment of high-risk osteosarcoma [273] and breast cancer metastatic to bone only [274] as well as phase I/II trials in combination with ...
57
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 ...
14
<p>Evaluating the Safety and Efficacy of Nivolumab in Patients with Advanced Hepatocellular Carcinoma: Evidence to Date</p>
... a Phase III ...recent Phase I/II clinical trials involving checkpoint inhibitors such as nivo- lumab and pembrolizumab demonstrated potential bene fi ts of immunotherapy in ...
8
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 ...
12
Ustekinumab in treatment of Crohn’s disease: design, development, and potential place in therapy
... through phase II and phase III trials (UNITI-1, UNITI-2, and IM-UNITI) for both induction and maintenance of clinical response and remission in moderate-to-severe Crohn’s ...
14
Activity monitors for increasing physical activity in adult stroke survivors
... early phase after stroke potentially limits the op- portunities of people with stroke to optimise functional recovery, particularly for standing and walking ...
13
Chemovirotherapy: combining chemotherapeutic treatment with oncolytic virotherapy
... Current clinical trials on chemovirotherapy are based on a plethora of encouraging results from numerous preclinical models and are obtained mostly by systematic approaches in which key features such as the ...
10
Dalfampridine sustained-release for symptomatic improvement of walking speed in patients with multiple sclerosis
... randomized to treatment with dalfampridine SR at doses of 10 mg, 15 mg, or 20 mg twice daily. Patients had to have a timed 25-foot walk (T25FW) of 8–60 seconds and be aged 18–70 years. The primary outcome measure was ...
6
Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations
... The world is facing an emerging threat of greater anti- biotic resistance [1]. New antibacterial technologies are needed to treat pathogens as they become increasingly resistant to existing antibiotics [1, 2]. Yet, the ...
10