scholarly journals Trial for detection of clinical test value abnormal fluctuation in clinical phase I test.

1997 ◽  
Vol 28 (1) ◽  
pp. 451-452
Author(s):  
SHIN'ICHI YOKOTA
Keyword(s):  
Phase I ◽  
Clinical Test ◽  
Clinical Phase

KP1019, A New Redox-Active Anticancer Agent - Preclinical Development and Results of a Clinical Phase I Study in Tumor Patients

2008 ◽  
Vol 5 (10) ◽  
pp. 2140-2155 ◽  
Author(s):  
Christian G. Hartinger ◽  
Michael A. Jakupec ◽  
Stefanie Zorbas-Seifried ◽  
Michael Groessl ◽  
Alexander Egger ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Anticancer Agent ◽  
Preclinical Development ◽  
Tumor Patients ◽  
Clinical Phase ◽  
Redox Active

scholarly journals Results from clinical phase I study on breast tumor ablation with dedicated breast MR-HIFU system

2015 ◽  
Vol 3 (S1) ◽  
Author(s):  
Floor Knuttel ◽  
Roel Deckers ◽  
Laura Merckel ◽  
Gerald Schubert ◽  
Max Kohler ◽  
...  
Keyword(s):  
Phase I ◽  
Breast Tumor ◽  
Phase I Study ◽  
Tumor Ablation ◽  
Clinical Phase ◽  
Breast Mr

scholarly journals Animal Safety, Toxicology, and Pharmacokinetic Studies According to the ICH S9 Guideline for a Novel Fusion Protein tTF-NGR Targeting Procoagulatory Activity into Tumor Vasculature: Are Results Predictive for Humans?

Cancers ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3536
Author(s):  
Wolfgang E. Berdel ◽  
Saliha Harrach ◽  
Caroline Brand ◽  
Kathrin Brömmel ◽  
Andrew F. Berdel ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Phase I ◽  
Tumor Vasculature ◽  
Good Manufacturing Practice ◽  
Pharmacokinetic Studies ◽  
Therapeutic Effects ◽  
Alternative Pathways ◽  
Clinical Phase ◽  
End Stage ◽  
Animal Safety

Background: CD-13 targeted tissue factor tTF-NGR is a fusion protein selectively inducing occlusion of tumor vasculature with resulting tumor infarction. Mechanistic and pharmacodynamic studies have shown broad anti-tumor therapeutic effects in xenograft models. Methods: After successful Good Manufacturing Practice (GMP) production and before translation into clinical phase I, ICH S9 (S6) guideline-conforming animal safety, toxicology, and pharmacokinetic (PK) studies were requested by the federal drug authority in accordance with European and US regulations. Results: These studies were performed in mice, rats, guinea pigs, and beagle dogs. Results of the recently completed clinical phase I trial in end-stage cancer patients showed only limited predictive value of these non-clinical studies for patient tolerability and safety in phase I. Conclusions: Although this experience cannot be generalized, alternative pathways with seamless clinical phase 0 microdosing—phase I dose escalation studies are endorsed for anticancer drug development and translation into the clinic.

Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine

2010 ◽  
pp. 281-307
Author(s):  
Hugh E. Black ◽  
Stephen B. Montgomery ◽  
Ronald W. Moch
Keyword(s):  
Phase I ◽  
Clinical Phase

scholarly journals OptimalTTF-1: Enhancing tumor treating fields therapy with skull remodeling surgery. A clinical phase I trial in adult recurrent glioblastoma

2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Anders Rosendal Korshoej ◽  
Slavka Lukacova ◽  
Yasmin Lassen-Ramshad ◽  
Christian Rahbek ◽  
Kåre Eg Severinsen ◽  
...  
Keyword(s):  
Phase I ◽  
Compliance Rate ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Oncological Treatment ◽  
Clinical Phase ◽  
Tumor Treating Fields ◽  
Skull Defects ◽  
Secondary Endpoints ◽  
First Recurrence

Abstract Background Preclinical studies suggest that skull remodeling surgery (SR-surgery) increases the dose of tumor treating fields (TTFields) in glioblastoma (GBM) and prevents wasteful current shunting through the skin. SR-surgery introduces minor skull defects to focus the cancer-inhibiting currents toward the tumor and increase the treatment dose. This study aimed to test the safety and feasibility of this concept in a phase I setting. Methods Fifteen adult patients with the first recurrence of GBM were treated with personalized SR-surgery, TTFields, and physician’s choice oncological therapy. The primary endpoint was toxicity and secondary endpoints included standard efficacy outcomes. Results SR-surgery resulted in a mean skull defect area of 10.6 cm2 producing a median TTFields enhancement of 32% (range 25–59%). The median TTFields treatment duration was 6.8 months and the median compliance rate 90%. Patients received either bevacizumab, bevacizumab/irinotecan, or temozolomide rechallenge. We observed 71 adverse events (AEs) of grades 1 (52%), 2 (35%), and 3 (13%). There were no grade 4 or 5 AEs or intervention-related serious AEs. Six patients experienced minor TTFields-induced skin rash. The median progression-free survival (PFS) was 4.6 months and the PFS rate at 6 months was 36%. The median overall survival (OS) was 15.5 months and the OS rate at 12 months was 55%. Conclusions TTFields therapy combined with SR-surgery and medical oncological treatment is safe and nontoxic and holds the potential to improve the outcome for GBM patients through focal dose enhancement in the tumor.

scholarly journals Clinical research on new drugs (Phase I). Profile of scientific publications: data from the pre-clinical phase and bioethical aspects

2008 ◽  
Vol 23 (6) ◽  
pp. 531-535 ◽  
Author(s):  
Vanessa de Souza Brick ◽  
William Saad Hossne ◽  
Rogério Saad Hossne
Keyword(s):  
Data Collection ◽  
Phase I ◽  
New Drugs ◽  
Human Beings ◽  
Scientific Publications ◽  
Future Studies ◽  
Clinical Phase ◽  
Sample Characteristics ◽  
Phase Data ◽  
Phase Phase

PURPOSE: To trace a profile of scientific publications, phase I, in order to know whether or not they show pre-clinical phase data, emphasizing bioethical aspects. METHODS: Sixty-one scientific articles, published in 2007, involving research in human beings using new drugs, medicines and vaccines during phase I were analysed. A schedule for data collection was elaborated in which it would be possible to analyse and evaluate those articles. The schedule included items related to the pre-clinical phase associated to the clinical phase, and items related to the sample characteristics. RESULTS: Most of research works were carried out in USA. Taking into consideration that a large number of works have been dedicated to oncologic affections, most of them were carried out in voluntary ill individuals. Information on the pre-clinical phase, phase I, was very poor or absent. Even though some authors consider the phase I research as a promising one and also suggest some future studies on phase II, the reader is not able to consider the same way, as long as there is a shortage of information on the pre-clinical phase. CONCLUSION: The profile of scientific publications showed that data deserve some reflections and analysis to better evaluate the publications on phase I.

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