[PDF] Top 20 Joint Modelling of Efficacy and Toxicity in the Dose Escalation Phase I Studies
Has 10000 "Joint Modelling of Efficacy and Toxicity in the Dose Escalation Phase I Studies" found on our website. Below are the top 20 most common "Joint Modelling of Efficacy and Toxicity in the Dose Escalation Phase I Studies".
Joint Modelling of Efficacy and Toxicity in the Dose Escalation Phase I Studies
... that toxicity has been the most prevalent endpoint used to define RD in phase I trials [13] ...have dose dependent toxicities and there is a need of additional data and para- meters to further ... See full document
11
Intensity modulated radiotherapy in locally advanced thyroid cancer: Outcomes of a sequential phase I dose-escalation study.
... long-term toxicity such as the swallowing ...reducing dose to the pharyngeal constrictor muscles that are involved in swallowing on long-term swallowing outcomes in an international, multicentre ... See full document
27
A Bayesian approach for dose escalation in a phase I clinical trial incorporating pharmacodynamic endpoints
... in phase I dose-escalation studies in healthy ...the dose-response relationship while avoiding excessive ...many dose-escalation studies, pharmacodynamic ... See full document
22
Phase I dose escalation safety study of nanoparticulate paclitaxel (CTI 52010) in normal dogs
... the dose-limiting toxicity was neutropenia. Gastrointestinal toxicity was mild and only seen in those dogs receiving high doses of ...gastrointestinal toxicity is a major con- cern for pet ... See full document
8
Phase I clinical trial of decitabine (5-aza-2'-deoxycytidine) administered by hepatic arterial infusion in patients with unresectable liver-predominant metastases
... the efficacy of subsequent treatment with immune check point ...a dose escalation phase I clinical ...different dose levels (two patients at 10, four at 15 and six at a ... See full document
6
PATRIOT: A phase I study to assess the tolerability, safety and biological effects of a specific ataxia telangiectasia and Rad3-related (ATR) inhibitor (AZD6738) as a single agent and in combination with palliative radiation therapy in patients with solid tumours.
... non-randomised phase I study of AZD6738 in advanced solid tumours with three parts: monotherapy dose-escalation (part A), monotherapy dose- expansion at maximum tolerated dose ... See full document
5
Phase I dose-escalation study of the mTOR inhibitor sirolimus and the HDAC inhibitor vorinostat in patients with advanced malignancy
... at dose level ...at dose level 6, had a gradual reduction by as much as 54% in sum of target lesions after 6 cycles of therapy and stayed on treatment for 8 ...imaging studies for these patients are ... See full document
11
Standard and hypofractionated dose escalation to intraprostatic tumour nodules in localised prostate cancer: efficacy and toxicity in the DELINEATE trial.
... . Studies have shown the feasibility for these techniques in DIL identification 11 , with ongoing studies investigating whether this additional information for radiotherapy planning is clinically ... See full document
33
Dose selection in seamless phase II/III clinical trials based on efficacy and toxicity
... each phase is carried out as a separate ...each phase, only one trial is required. However, for example in phase II, two or more trials may be carried ...in phase II, the first trial may be a ... See full document
152
BCL-2 as therapeutic target for hematological malignancies
... Clinical studies with venetoclax in monotherapy in CLL Based on the promising preclinical results, a first-in- human phase 1 dose-escalation study was conducted to investigate the safety and ... See full document
15
Immunotherapy and pancreatic cancer: unique challenges and potential opportunities.
... PDAC presents an extremely difficult malig- nancy to treat. Its poor immunogenicity, unique TME and high levels of immunosuppression pro- vide significant challenges when considering immunotherapy as a therapeutic ... See full document
20
Neoadjuvant stereotactic radiosurgery for intracerebral metastases of solid tumors (NepoMUC): a phase I dose escalation trial
... late toxicity of CTCAE grade 1–5, immunological parameters, time interval between treatment initiation and start of systemic chemotherapy), Fisher’s exact test or Chi-square test (local control rates), log-rank ... See full document
9
Phase I randomized dose ascending placebo controlled trials of ferroquine a candidate anti malarial drug in adults with asymptomatic Plasmodium falciparum infection
... human studies showing prolongation of the QT interval for chloroquine a spe- cial emphasis was laid on the assessment of cardiac effects ...repeated dose study with T wave mor- phology changes on their ECG ... See full document
11
A clinical trial of enteral Levetiracetam for acute seizures in pediatric cerebral malaria
... The dose escalation study was designed to identify the dose which would be effective for most patients but did not delineate what dose of eLVT might benefit a child with refractory ... See full document
12
<p>Pharmacokinetic Evaluation by Modeling and Simulation Analysis of a Donepezil Patch Formulation in Healthy Male Volunteers</p>
... two phase I studies in Korean male subjects: Study ...A phase I clinical, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in ... See full document
9
A Phase I Dose Escalation Trial of Gemcitabine with Radiotherapy for Breast Cancer in the Treatment of Unresectable Chest Wall Recurrences
... the dose level of 450 mg / m 2 / week, was ...common toxicity encountered during treatment was the expected grade 3 skin dermatitis secondary to radiotherapy occurring by the end of ... See full document
7
Safety and tolerability of conditioning chemotherapy followed by CD19-targeted CAR T cells for relapsed/refractory CLL
... in patients with B-ALL), rates of grade ≥ 3CRS and neurologic toxicity were only 10%, though all patients developed CRS, and transient grade 1–2 neurologic toxicities were not uncommon (35%). Observed rates of CR ... See full document
18
Safety and immunogenicity of the PRAME cancer immunotherapeutic in metastatic melanoma: results of a phase I dose escalation study
... Figure 2 PRAME-specific CD4+ T-cell (TNF- α +/IFN- γ +) immunogenicity scores and cellular response prior to treatment and postdose 4 (ATP cohort for immunogenicity). Footnote: N=number of patients with available ... See full document
7
Clinical potential of SLAMF7 antibodies – focus on elotuzumab in multiple myeloma
... escalating dose cohorts, with intravenous Elo doses ranging from ...tolerated dose (MTD) was identified up to the maximum planned dose (MPD) of 20 ...first dose of Elo in the 20 mg/kg dosing ... See full document
8
Pomalidomide: a novel drug to treat relapsed and refractory multiple myeloma
... tolerated dose of pomalidomide was 2 ...Gastrointestinal toxicity grade 1 and 2, skin toxicity grade 1, and neuropathy grade 1 were reported in four (18%), four (18%), five (21%) and three (16%) ... See full document
8
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