PURPOSE: The primary goal of this open-label, multicenter, randomized phase III trial was to determine whether treatment with carboplatin plus the oral fluoropyrimidine derivative S-1 was noninferior versus that with carboplatin plus paclitaxel with regard to overall survival (OS) in chemotherapy-naive...
Purpose: To evaluate the efficacy and safety of a bilateral injection of lenadogene nolparvovec in patients with Leber Hereditary Optic Neuropathy (LHON) carrying the m.11778G > A mutation. Methods: REFLECT is a randomized, placebo‐controlled, phase 3 study that included 98 patients with ...
legal foundations for phase 2/3 designs. By the U.S. constitution, the FDA interprets and executes laws but has no authority to make laws. Thus, the chapter article serves the purpose of informing regulators from the FDA of their responsibilities to implement the laws despite their personal ...
Phase I trial of docetaxel given every 3 weeks and daily lenalidomide in patients with advanced solid tumors. PURPOSE: Cytotoxic and anti-angiogenic drugs are efficacious in malignancies. This trial was undertaken to evaluate the toxicity of a novel regimen combini... SL Sanborn,J Gibbons,S Kris...
Purpose There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II ...
PURPOSE: Temsirolimus, a specific inhibitor of the mammalian target of rapamycin kinase, has shown clinical activity in mantle cell lymphoma (MCL). We eval... G Hess,R Herbrecht,J Romaguera,... - 《Journal of Clinical Oncology》 被引量: 1588发表: 2009年 Phase III study of concurrent chemo...
PURPOSE: Palifosfamide is the active metabolite of ifosfamide and does not require prodrug activation, thereby avoiding the generation of toxic metabolites. The PICASSO III trial compared doxorubicin plus palifosfamide with doxorubicin plus placebo in patients who had received no prior systemic therapy fo...
controlled trials41,44. For example, the concurrent provision of intensive lifestyle intervention (plus meal replacements) and semaglutide 2.4 mg in the STEP-3 trial produced a mean weight loss of 16.0%, which was comparable to that observed in the STEP-1 study (14.9%) in a similar ...
Purpose To assess the safety and efficacy of fostamatinib in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Experimental design Relapsed or refractory DLBCL patients originally received the oral spleen tyrosine kinase inhibitor, fostamatinib in a two-arm, randomised, double...
Final report of multicenter Canadian Phase III randomized trial of 3 versus 8 months of neoadjuvant androgen deprivation therapy before conventional-dose radiotherapy for clinically localized prostate cancer. Purpose:To evaluate the effect of 3 vs. 8 months of neoadjuvant hormonal therapy before convention...