A phase II clinical study of 13‐deoxy, 5‐iminodoxorubicin (GPX‐150) with metastatic and unresectable soft tissue sarcoma
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DOI: 10.1002/cam4.2136
Abstract: 13‐Deoxy, 5‐iminodoxorubicin (GPX‐150) is a doxorubicin (DOX) analog synthesized to reduce the formation of reactive oxygen species and the cardiotoxic metabolite, doxorubiciniol, the two pathways that are linked to the irreversible, cumulative dose‐dependent cardiotoxicity of… read more here.
Keywords: deoxy iminodoxorubicin; iminodoxorubicin gpx; clinical study; gpx 150 ... See more keywords
Survival and clinical outcomes of patients with ovarian cancer who were treated on phase 1 clinical trials
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DOI: 10.1002/cncr.33073
Abstract: Patients with ovarian cancer who are enrolled on phase 1 trials typically have platinum‐resistant and heavily pretreated disease, with a poor prognosis. In the current study, the authors assessed prognostic factors and survival in women… read more here.
Keywords: treated phase; ovarian cancer; patients ovarian; cancer ... See more keywords
Review of the Chinese Landscape in Phase 1 Clinical Trials for Noncancer Innovative Drugs Over 2015 to 2020
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DOI: 10.1002/cpdd.1131
Abstract: In recent years, the research and development (R&D) of innovative drugs in China has been dramatically accelerated. And the early clinical study is crucial for drug R&D. However, little is known involving the change of… read more here.
Keywords: clinical trials; innovative drugs; drug; phase clinical ... See more keywords
Pooled Population Pharmacokinetic Analyses of Venetoclax in Patients Across Indications and Healthy Subjects from Phase 1, 2 and 3 Clinical Trials.
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DOI: 10.1002/jcph.2248
Abstract: Following the decade long clinical investigation, venetoclax has accrued PK data across multiple populations and widely-ranging demographics, intrinsic, and extrinsic factors. We leveraged these rich data to systematically characterize venetoclax PK and assess covariate effects… read more here.
Keywords: indications healthy; cyp3a; pooled population; inhibitor ... See more keywords
Implementation of adaptive methods in early-phase clinical trials.
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DOI: 10.1002/sim.6910
Abstract: There has been constant development of novel statistical methods in the design of early-phase clinical trials since the introduction of model-based designs, yet the traditional or modified 3+3 algorithmic design remains the most widely used… read more here.
Keywords: early phase; clinical trials; implementation adaptive; phase clinical ... See more keywords
Clinical Studies of Methionine-Restricted Diets for Cancer Patients.
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DOI: 10.1007/978-1-4939-8796-2_9
Abstract: Methionine (MET) restriction (MR) has been shown to arrest cancer growth and sensitizes tumors to chemotherapy. MR total parenteral nutrition (MR TPN) with a chemotherapy-containing amino acid solution ("AO-90") (lacking both MET and L-cysteine[CYS]) showed… read more here.
Keywords: clinical trial; studies methionine; clinical studies; cancer ... See more keywords
Evolution of early phase clinical trials in oncology
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DOI: 10.1007/s00109-017-1612-7
Abstract: The therapeutic armamentarium for the treatment of cancer has rapidly evolved with the advent of molecularly targeted and immuno-oncology agents. Dramatic and prolonged responses observed in patients with advanced cancers have created excitement and promise… read more here.
Keywords: trials oncology; early phase; clinical trials; oncology ... See more keywords
Triumphs and tribulations of COVID-19 vaccines: Lessons to be learned from smallpox epidemics in the 1700s
Sign Up to like & getrecommendations! Published in 2021 at "Virchows Archiv"
DOI: 10.1007/s00428-021-03020-w
Abstract: The recent years have been threatened by emerging and reemerging pathogens, like influenza viruses, Ebola virus, Zika virus, and, currently, SARS-CoV-2, which have rapidly spread globally causing large epidemics with devastating health and economic consequences.… read more here.
Keywords: covid vaccines; variolation; clinical trials; vaccine ... See more keywords
New concept for treating urinary incontinence after radical prostatectomy with radiofrequency: phase 1 clinical trial
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DOI: 10.1007/s10103-019-02784-7
Abstract: To describe the clinical response and side effects of radiofrequency treatment in patients with urinary incontinence after radical prostatectomy. This is a phase 1 clinical trial with 10 men up to 65 years of age who… read more here.
Keywords: incontinence radical; incontinence; urinary incontinence; radical prostatectomy ... See more keywords
Factors affecting symptom presentation in an early-phase clinical trials clinic patient population
Sign Up to like & getrecommendations! Published in 2019 at "Investigational New Drugs"
DOI: 10.1007/s10637-019-00879-0
Abstract: Increasing numbers of oncology therapies are being approved based on early-phase single-arm studies. Yet, little is known regarding the use of patient-reported outcomes in single-arm oncology trials testing novel therapies. We examined patient-reported symptom severity… read more here.
Keywords: phase; early phase; symptom severity; severity ... See more keywords
Pooled Analysis of Clinical Outcome of Patients with Chemorefractory Metastatic Colorectal Cancer Treated within Phase I/II Clinical Studies Based on Individual Biomarkers of Susceptibility: A Single-Institution Experience
Sign Up to like & getrecommendations! Published in 2017 at "Targeted Oncology"
DOI: 10.1007/s11523-017-0505-6
Abstract: BackgroundPatients with metastatic colorectal cancer (mCRC) refractory to standard therapies have a poor prognosis. In this setting, recruitment into clinical trials is warranted, and studies driven by selection according to individual tumor molecular characteristics are… read more here.
Keywords: metastatic colorectal; clinical studies; colorectal cancer; cancer ... See more keywords