Abstract A035: Pharmacokinetics and pharmacodynamics of the immunotherapeutic TLR-9 agonist MGN1703 – conclusions by comparison of data from clinical trials with healthy volunteers and cancer patients

Background/Aim: Diarrhea is among the most common adverse events in early oncology clinical trials, and drug causality may be difficult to determine. Materials and Methods: This is a systematic literature review of placebo arms of randomized cancer trials. Results: Anemia was reported in 95 of 127 placebo monotherapy cohorts. Publications involving healthy volunteers and cancer prevention studies reported lower frequencies than those with cancer patients. The average reported frequency of diarrhea grade 1 or higher among studies in cancer patients was 15%. The maximal reported frequencies for grades 1, 2, 3, 4, 5 were 56, 24, 6, 2, and 0%, respectively. Conclusion: When higher diarrhea frequencies than those are observed in treatment arms of clinical trials, then drug causality is likely.

Download Full-text

32 Safety, pharmacokinetics and pharmacodynamics of BI 705564, a covalent inhibitor of brutons tyrosine kinase in phase 1 clinical trials in healthy volunteers

10.1136/lupus-2019-lsm.32 ◽

2019 ◽

Author(s):

Tobias Litzenburger ◽

Fabian Müller ◽

Armin Schultz ◽

Elliott Klein ◽

Meera Ramanujam ◽

...

Keyword(s):

Clinical Trials ◽

Tyrosine Kinase ◽

Healthy Volunteers ◽

Phase 1 ◽

Pharmacokinetics And Pharmacodynamics ◽

Covalent Inhibitor

Download Full-text

TRANSDERMAL FENTANYL: PHARMACOLOGICAL ASPECTS OF THERAPY IN CANCER PATIENTS. PART 1. FROM THE DEVELOPMENT OF TRANSDERMAL FENTANYL FORMULATIONS TILL META-ANALYSES OF CLINICAL TRIALS

Russian Journal of Oncology ◽

10.18821/1028-9984-2017-22-3-122-130 ◽

2017 ◽

Vol 22 (3) ◽

pp. 122-130

Author(s):

Aleksander V. Sidorov

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Therapeutic Equivalence ◽

Matrix System ◽

Efficacy And Safety ◽

Pharmacokinetics And Pharmacodynamics ◽

Transdermal Fentanyl ◽

Basic Principles ◽

Transdermal Patches ◽

Meta Analyses

There was given a review of data on pharmacology of fentanyl with focus on transdermal formulation. In the first part of the article improvements in technology of fentanyl transdermal patches were reviewed and advantages of the membrane-matrix system that are of practical use were highlighted. The results obtained from bioequivalence and therapeutic equivalence studies of traditional and improved transdermal fentanyl systems were given. Clinical trials with fentanyl transdermal patches as well as systematic reviews and meta-analyses on the efficacy and safety of transdermal fentanyl were summarized. The second part of the article will focus on factors contributing to the variability in pharmacokinetics and pharmacodynamics of fentanyl including pharmacogenetics; the taking into account the whole spectrum of these factors would allow to escaped the majority of errors during the administration of the drug e.g. transdermally. A special attention will be paid to basic principles and issues of the application of fentanyl transdermal therapeutic systems.

Download Full-text

Taking Part in Clinical Trials:: What Cancer Patients Need To Know

PsycEXTRA Dataset ◽

10.1037/e408492005-001 ◽

1998 ◽

Author(s):

Keyword(s):

Clinical Trials ◽

Cancer Patients

Download Full-text

Treatment and secondary prevention of venous thromboembolism in cancer patients

Onkologische Welt ◽

10.1055/s-0038-1630173 ◽

2012 ◽

Vol 03 (03) ◽

pp. 121-125

Author(s):

I. Pabinger ◽

C. Ay

Keyword(s):

Clinical Trials ◽

Venous Thromboembolism ◽

Cancer Patients ◽

Oral Anticoagulants ◽

Factor Xa ◽

New Oral Anticoagulants ◽

Phase Iii ◽

Patients With Cancer ◽

Potential Use

SummaryCancer is a major and independent risk factor of venous thromboembolism (VTE). In clinical practice, a high number of VTE events occurs in patients with cancer, and treatment of cancerassociated VTE differs in several aspects from treatment of VTE in the general population. However, treatment in cancer patients remains a major challenge, as the risk of recurrence of VTE as well as the risk of major bleeding during anticoagulation is substantially higher in patients with cancer than in those without cancer. In several clinical trials, different anticoagulants and regimens have been investigated for treatment of acute VTE and secondary prophylaxis in cancer patients to prevent recurrence. Based on the results of these trials, anticoagulant therapy with low-molecular-weight heparins (LMWH) has become the treatment of choice in cancer patients with acute VTE in the initial period and for extended and long-term anticoagulation for 3-6 months. New oral anticoagulants directly inhibiting thrombin or factor Xa, have been developed in the past decade and studied in large phase III clinical trials. Results from currently completed trials are promising and indicate their potential use for treatment of VTE. However, the role of the new oral thrombin and factor Xa inhibitors for VTE treatment in cancer patients still has to be clarified in further studies specifically focusing on cancer-associated VTE. This brief review will summarize the current strategies of initial and long-term VTE treatment in patients with cancer and discuss the potential use of the new oral anticoagulants.

Download Full-text