Phase I Dose Escalation of Doxorubicin Chemotherapy in Tumor-Bearing Equidae
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منابع مشابه
Phase I Dose-Escalation Study of Nimustine in Tumor-Bearing Dogs
Nimustine (ACNU) is an alkylating agent of the nitrosourea and can be an antineoplastic agent in dogs. But, there has been no report on its dose-limiting toxicity (DLT) in dogs. This study was a phase I dose-escalation clinical trial to determine the maximum tolerated dose (MTD) and DLT of ACNU in tumor-bearing dogs. The starting dosage was 25 mg/m(2), and subsequent dosages were administered i...
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Phase I clinical trials are an essential step in the development of anticancer drugs. The main goal of these studies is to establish the recommended dose and/or schedule of new drugs or drug combinations for phase II trials. The guiding principle for dose escalation in phase I trials is to avoid exposing too many patients to subtherapeutic doses while preserving safety and maintaining rapid acc...
متن کاملDose escalation with over-dose and under-dose controls in Phase I/II clinical trials.
To save valuable time and resources in new drug development, Phase I/II clinical trials with toxicity control and drug efficacy as dual primary endpoints have become increasingly popular. Escalation with over-dose control (the EWOC) is a Bayesian adaptive Phase I clinical trial design that can accurately estimate the maximum tolerated dose (MTD) level and control the probability of overdosing p...
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Recombinant interleukin (IL)-18 (SB-485232) is an immunostimulatory cytokine, with shown antitumor activity in combination with pegylated liposomal doxorubicin (PLD) in preclinical models. This phase I study evaluated the safety, tolerability, and biologic activity of SB-485232 administered in combination with PLD in subjects with recurrent ovarian cancer. The protocol comprised four cycles of ...
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BACKGROUND Statistical simulations have consistently demonstrated that new dose-escalation designs such as accelerated titration design (ATD) and continual reassessment method (CRM)-type designs outperform the standard "3+3" design in phase I cancer clinical trials. METHODS We evaluated the actual efficiency of different dose escalation methods employed in first-in-human phase I clinical tria...
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ژورنال
عنوان ژورنال: Journal of Veterinary Internal Medicine
سال: 2013
ISSN: 0891-6640
DOI: 10.1111/jvim.12145