Dosimetric impact of the positioning variation of tumor treating field electrodes in the PriCoTTF‐phase I/II trial
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Applied Clinical Medical Physics"
DOI: 10.1002/acm2.13144
Abstract: Abstract Purpose The aim of the present study based on the PriCoTTF‐phase I/II trial is the quantification of skin‐normal tissue complication probabilities of patients with newly diagnosed glioblastoma multiforme treated with Tumor Treating Field (TTField)… read more here.
Keywords: trial; ttfield; variation; pricottf phase ... See more keywords
A phase II trial of regorafenib in patients with advanced Ewing sarcoma and related tumors of soft tissue and bone: SARC024 trial results
Sign Up to like & getrecommendations! Published in 2022 at "Cancer Medicine"
DOI: 10.1002/cam4.5044
Abstract: Regorafenib is one of several FDA‐approved cancer therapies targeting multiple tyrosine kinases. However, there are few subtype‐specific data regarding kinase inhibitor activity in sarcomas. We report results of a single arm, phase II trial of… read more here.
Keywords: trial regorafenib; trial; phase trial; regorafenib patients ... See more keywords
Standard versus low‐dose nab‐paclitaxel in previously treated patients with advanced non‐small cell lung cancer: A randomized phase II trial (JMTO LC14‐01)
Sign Up to like & getrecommendations! Published in 2023 at "Cancer Medicine"
DOI: 10.1002/cam4.5652
Abstract: Nab‐paclitaxel (nab‐PTX) has better transfer to tumor tissue than cremophor‐based paclitaxel. It suggests that the optimum dose of nab‐PTX might be lower than the dose and schedule that is widely used. We designed a randomized… read more here.
Keywords: dose nab; previously treated; nab paclitaxel; phase trial ... See more keywords
A subset analysis of a phase II trial evaluating the use of DFMO as maintenance therapy for high‐risk neuroblastoma
Sign Up to like & getrecommendations! Published in 2020 at "International Journal of Cancer"
DOI: 10.1002/ijc.33044
Abstract: Neuroblastoma is a sympathetic nervous system tumor, primarily presenting in children under 6 years of age. The long‐term prognosis for patients with high‐risk neuroblastoma (HRNB) remains poor despite aggressive multimodal therapy. This report provides an update… read more here.
Keywords: therapy; dfmo maintenance; phase trial;
Proxalutamide in metastatic castration-resistant prostate cancer: primary analysis of a multicenter, randomized, open-label, phase 2 trial.
Sign Up to like & getrecommendations! Published in 2023 at "International journal of cancer"
DOI: 10.1002/ijc.34512
Abstract: We aim to assess the safety and efficacy of proxalutamide, a novel androgen receptor antagonist, for men with metastatic castration-resistant prostate cancer (mCRPC) in a multicenter, randomized, open-label, phase 2 trial. In our study, the… read more here.
Keywords: phase trial; metastatic castration; prostate; cancer ... See more keywords
Safety and immunogenicity of a recombinant receptor‐binding domain‐based protein subunit vaccine (Noora vaccine™) against COVID‐19 in adults: A randomized, double‐blind, placebo‐controlled, Phase 1 trial
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Medical Virology"
DOI: 10.1002/jmv.28097
Abstract: The development of a safe and effective vaccine is essential to protect populations against coronavirus disease 2019 (COVID‐19). There are several vaccine candidates under investigation with different mechanisms of action. In the present study, we… read more here.
Keywords: safety immunogenicity; safety; placebo; phase trial ... See more keywords
Penpulimab, an anti-PD1 IgG1 antibody in the treatment of advanced or metastatic upper gastrointestinal cancers
Sign Up to like & getrecommendations! Published in 2022 at "Cancer Immunology, Immunotherapy"
DOI: 10.1007/s00262-022-03160-1
Abstract: The safety and anti-tumor activity of penpulimab in patients with advanced upper gastrointestinal (UGI) cancers were evaluated in this study. Patients with advanced UGI cancers naive to immune checkpoint inhibitors were enrolled in two trials… read more here.
Keywords: safety; ugi cancers; phase trial; trial ... See more keywords
Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence
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DOI: 10.1007/s10549-020-05638-x
Abstract: Purpose AE37 and GP2 are HER2 derived peptide vaccines. AE37 primarily elicits a CD4+ response while GP2 elicits a CD8+ response against the HER2 antigen. These peptides were tested in a large randomized trial to assess their… read more here.
Keywords: cancer patients; breast cancer; cancer; her2 ... See more keywords
Natalizumab for Achieving Relapse-Free, T1 Gadolinium-Enhancing-Lesion-Free, and T2 Lesion-Free Status in Japanese Multiple Sclerosis Patients: A Phase 2 Trial Subanalysis
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DOI: 10.1007/s40120-016-0062-4
Abstract: AbstractIntroductionIn a phase 2 trial of natalizumab in Japanese patients with relapsing-remitting multiple sclerosis (RRMS), treatment-related changes in relapses, brain lesions, and disability worsening were found to be comparable with those observed in the phase… read more here.
Keywords: status; lesion free; subanalysis; lesion ... See more keywords
Adverse Reactions in a Phase 1 Trial of the Anti-Malarial DM1157: An Example of Pharmacokinetic Modeling and Simulation Guiding Clinical Trial Decisions
Sign Up to like & getrecommendations! Published in 2022 at "Infectious Diseases and Therapy"
DOI: 10.1007/s40121-022-00605-z
Abstract: There is an urgent need to develop new drugs to treat malaria due to increasing resistance to first-line therapeutics targeting the causative organism, Plasmodium falciparum (P. falciparum). One drug candidate is DM1157, a small molecule… read more here.
Keywords: modeling simulation; dm1157; phase trial; trial ... See more keywords
Extensions of the 2-in-1 adaptive design.
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DOI: 10.1016/j.cct.2020.106053
Abstract: The 2-in-1 adaptive design [Chen et al. 2018] allows seamless expansion of an ongoing Phase 2 trial into a Phase 3 trial to expedite a drug development program. An intermediate endpoint can be used for… read more here.
Keywords: phase trial; expansion; adaptive design; design ... See more keywords