Phase I clinical trials
Accelerated Titration Designs for Phase I Clinical Trials in Oncology
... in phase I clinical trials are treated at doses of chemotherapeutic agents that are below the biologically active level, thus reducing their chances for therapeutic ...Current phase ...
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Outcomes of patients with advanced cancer and KRAS mutations in phase I clinical trials
... the Phase I Clinical Trials Program required that participants have evidence of evaluable or measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) ...
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Dose finding methods for Phase I clinical trials using pharmacokinetics in small populations
... of phase I clinical trials is to obtain reliable information on safety, tolerability, pharmacokinetics (PK), and mechanism of action of drugs with the objective of determining the maximum ...
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Validation of prognostic scoring and assessment of clinical benefit for patients with bone sarcomas enrolled in phase I clinical trials
... specified. In the present study, compared with the RMH scoring system, the MDACC system accounted for only 1 additional variable—ECOG performance status, which resulted in prognostic scores of 0-4, rather than 0-3—and ...
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dfpk : An R package for Bayesian dose finding designs using Pharmacokinetics (PK) for phase I clinical trials
... 4. Conclusion The dfpk package implements novel methods for dose-finding phase I clinical trials incorporating PK in the dose-toxicity rela- tionships [8] . In this package, each method can be ...
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Bayesian Model Averaging CRM in Phase I Clinical Trials
... • Skeleton 1 is for the case in which toxicity increases slowly at the low doses but increases quickly at the high doses. • Skeleton 2 is more concentrated at the low toxicity[r] ...
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Insurance and compensation in the event of injury in Phase I clinical trials
... of Phase I trials, the right of the volunteer to claim compensation from the Sponsor is not affected because, as described in paragraph 2 above, the Sponsor’s undertaking to pay compensation is given ...
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A privacy preserving protocol for tracking participants in phase I clinical trials
... In our case, first name + last name + postal code produces 7 + 1 + 7 + 1 + 6 + 1 = 23 bigrams). The maximum size of a dataset we considered for our clinical trial setup is 20,000. If a protocol performed one to one ...
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TITE-CRM Phase I Clinical Trials: Implementation Using SAS
... In the next example, escalation does not occur until three completed observation periods. The titecrm.sas program parameters are level1 = 1, rshceme = 13, dosejump = 1 and nproceed = 3 (Table 12). The target probability ...
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Innovative phase I clinical trials based on patient genotype monitoring
... gas phase ions production from the small/highly charged droplets has been investigated by several authors, as discussed in some recent reviews (Crotti et ...mobile phase flow rate and by the use of volatile ...
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Bayesian adaptive methods to incorporate preclinical data into phase I clinical trials
... prior, respectively. The presented methodologies are, however, quite differential in technical details and how we are concerned with heterogeneity both between studies and between species. In Chapter 2 , we follow the ...
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Clinical outcomes and prognostic factors of patients with advanced mesothelioma treated in a phase I clinical trials unit.
... Given the uncertain benefits of post first line chemotherapy, clinical trials including phase I studies, should be considered for patients who remain fit (e.g. Eastern Cooperative Oncology ...
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Palliative Care: A Supportive Adjunct to Pediatric Phase I Clinical Trials for Anticancer Agents?
... adult phase I trials, pediatric phase I trials generally have a 5% to 8% response ...pediatric phase I trials because the likelihood of risk and discomfort ...
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The Cost of Cancer Care: Patient Navigation Challenges to Participation in Phase I Clinical Trials
... department to be interactive or provide assistance to the various outside financial assistance support which may be unique to individual patients. Thus the proof of principle provided in this assessment largely involving ...
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Translational potential of a mouse in vitro bioassay in predicting gastrointestinal adverse drug reactions in Phase I clinical trials.
... the clinical settings and the assay is important in determining safety ...Compound I was tested at a maximum concentration that was only twofold greater than the maximum therapeutic dose used, and it is ...
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Complications of hyperglycaemia with PI3K-AKT-mTOR inhibitors in patients with advanced solid tumours on Phase I clinical trials.
... 18 phase I trials involving PI3K, AKT, mTOR and multikinase PI3K/mTOR inhibitors, both as single agents or in combination with cytotoxic chemotherapy or other targeted ...These trials included ...
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Bayesian Phase I/II clinical trials in Oncology
... Bayesian Phase I/II clinical trials in Oncology... Phase I clinical trials in oncology.[r] ...
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Promising investigational drug candidates in phase I and phase II clinical trials for mesothelioma
... II phase trial has been planned [28]. Phase I clinical trials have been recently completed or are still ongoing testing the safety of WT1-based vaccines (NCT00398138) which evaluate WT1 ...
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THE RAPID ENROLLMENT DESIGN FOR PHASE I CLINICIAL TRIALS
... References Bekele, B. N., Ji, Y., Shen, Y., and Thall, P. F. (2008). Monitering late-onset toxicities in phase I trials using predited risks . Biostatistics 9(3), 442-457. Cheung, Y.K. and Chappell, ...
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Phase I and phase II sonidegib and vismodegib clinical trials for the treatment of paediatric and adult MB patients: a systemic review and meta-analysis
... A Phase I clinical trials of vismodegib has demonstrated a 60% response rate in locally advanced or metastatic BCC ...Current clinical trial data has shown varying responses to the ...
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