A5103175061- Lung Cancer Treatments and Mutations
- Lung Cancer Research Studies
- Cancer Immunotherapy and Biomarkers
- Lung Cancer Diagnosis and Treatment
- Hepatocellular Carcinoma Treatment and Prognosis
- Angiogenesis and VEGF in Cancer
- Colorectal Cancer Treatments and Studies
- Cancer Genomics and Diagnostics
- Cancer Treatment and Pharmacology
- Estrogen and related hormone effects
- Cancer, Hypoxia, and Metabolism
- Renal cell carcinoma treatment
- Prostate Cancer Treatment and Research
- Nausea and vomiting management
- Cystic Fibrosis Research Advances
- Hormonal and reproductive studies
- Cancer Mechanisms and Therapy
- Catalytic Processes in Materials Science
- Cancer-related Molecular Pathways
- Microtubule and mitosis dynamics
- Epigenetics and DNA Methylation
- Peptidase Inhibition and Analysis
- Breast Cancer Treatment Studies
- Pancreatic and Hepatic Oncology Research
- Adrenal Hormones and Disorders
Johannes Gutenberg University Mainz
2018-2023
Boehringer Ingelheim (Germany)
2014-2023
Kindai University
2010-2023
Evangelisches Krankenhaus Hamm
2022
University Medical Center of the Johannes Gutenberg University Mainz
2018
University of Göttingen
2003-2017
Boehringer Ingelheim (United States)
2010-2017
Boehringer Ingelheim (Taiwan)
2017
Boehringer Ingelheim (Australia)
2017
Reckitt Benckiser (United States)
2016
PURPOSE: The use of serotonin 5-hydroxytryptamine type 3 receptor antagonists has substantially reduced, but not eliminated, nausea and vomiting in cancer chemotherapy. This study sought to investigate whether efficacy antiemetic treatment with ondansetron tropisetron depends on cytochrome P-450 2D6 (CYP2D6) genotype, hypothesizing that the rapid particularly ultrarapid metabolizers these drugs are at risk being undertreated. PATIENTS AND METHODS: Included were 270 patients receiving their...
BIBF 1120 is an oral, potent angiokinase inhibitor targeting receptors of the vascular endothelial growth factors, platelet-derived and fibroblast factors. This phase I, accelerated titration study assessed maximum tolerated dose, safety, pharmacokinetics, pharmacodynamic effects 1120.Sixty-one patients with advanced cancers received in successive cohorts. Twenty-five 50 to 450 mg once daily 36 150 300 twice 4-week treatment courses interspersed by 1 week washout. Dynamic contrast-enhanced...
BI 2536 is a novel, potent, and highly specific inhibitor of polo-like kinase 1 (Plk1), which has an essential role in the regulation mitotic progression. The aim this trial was to identify maximum tolerated dose (MTD) determine safety, pharmacokinetics, antitumor activity patients who had advanced solid tumors.This phase I followed open label, toxicity-guided, dose-titration design. Single doses (25 250 mg) were administered as 1-hour intravenous infusion; experienced clinical benefit...
Purpose: Serotonin (5-hydroxytryptamine type 3 [5-HT ]) receptor antagonists have substantially reduced but not eliminated nausea and vomiting in patients undergoing cancer chemotherapy. They act through specific binding to the 5-HT 3A , 3B complex. The subunit seems be most important for its functionality. We hypothesized that with genetic variations gene might respond differently antiemetic treatment. Patients Methods: included 242 on their first day of Nausea were documented before twice...
BIBF 1120 is an oral multitargeted tyrosine kinase inhibitor that blocks the activity of vascular endothelial growth factor (VEGF) and other receptors. We have done a phase I study to evaluate safety, pharmacokinetics, pharmacodynamic biomarkers 1120. Patients with advanced refractory solid tumors were treated at doses 150 250 mg twice daily. Drug safety pharmacokinetics evaluated, as baseline post-treatment levels circulating CD117-positive bone marrow-derived progenitor cells plasma...
BIBF 1120 (planned brand name Vargatef) is a novel, oral, triple angiokinase inhibitor targeting three receptor classes involved in blood vessel formation. The objectives of this phase I, open-label dose-escalation study were to determine the safety, tolerability, and maximum tolerated dose (MTD) with pemetrexed patients recurrent advanced-stage non-small cell lung carcinoma.Patients harboring tumor any carcinoma histology, previously treated one first-line platinum-based chemotherapy...
8034 Background: Nintedanib (N) is an oral inhibitor of VEGFR, FGFR, and PDGFR. This global phase 3 study investigated the safety efficacy N + pemetrexed (PEM) vs placebo (P) PEM in patients (pts) with advanced, non-squamous NSCLC previously treated chemotherapy. Methods: Pts were randomized 1:1 to 200 mg po bid 500 mg/m 2 iv q21d (n=353, Arm A) or P (n=360, B). Continuation until PD unacceptable toxicity N, P, PEM, a combination was permitted. 1° endpoint centrally reviewed PFS. The null...
Background: This open-label phase i study with an accelerated titration design was performed to determine the maximum tolerated dose of BI 2536, a potent, highly selective small-molecule polo-like kinase 1 (Plk1) inhibitor. Methods: Patients advanced solid tumours received single 60-minute intravenous infusion 2536 (50–70 mg) on days 1–3 each 21-day treatment course. Recipients without disease progression or untenable toxicity could receive additional courses. The determined based...
The pharmacokinetics and metabolism of BIBF 1120, an oral triple angiokinase inhibitor targeting vascular endothelial growth factor receptor (VEGFR), platelet-derived (PDGFR), fibroblast (FGFR), were studied in healthy male volunteers (n = 8) who had received a single dose 100 mg [14C]-radiolabelled 1120 administered as solution.BIBF was well-tolerated rapidly absorbed; median time to reach maximum plasma concentrations 1.3 h gMean terminal half-life 13.7 h. A relatively high apparent total...
The LUME-Lung 1 trial (NCT00805194; Study 1199.13) demonstrated a significant overall survival (OS) advantage for nintedanib plus docetaxel compared with placebo as second-line therapy patients advanced non-small cell lung cancer (NSCLC) and adenocarcinoma histology. Patient-reported outcomes (PROs) symptoms health-related quality of life (QoL) are reported here.PROs were assessed at screening, on Day each 21-day treatment cycle, the end active treatment, first follow-up visit. PRO...
Abstract Nintedanib, a triple angiokinase inhibitor, has undergone clinical investigation for the treatment of solid tumors and idiopathic pulmonary fibrosis. Nintedanib (Vargatef ® ) plus docetaxel is approved in EU patients with adenocarcinoma non‐small cell lung cancer (NSCLC) after first‐line chemotherapy, as monotherapy (Ofev United States Pharmacokinetics (PK) nintedanib oral single multiple doses intravenous (IV) administration were assessed using 3 data sets: (1) an absolute...
Melphalan is associated with severe side effects such as mucositis, diarrhea, and myelosuppression. We investigated how much the individual severity of these predicted by pharmacokinetics. In addition, we studied glutathione S-transferase GSTM1, GSTT1, GSTP1 polymorphisms in relation to adverse events. A high interindividual pharmacokinetic variability was observed 84 patients. There a linear correlation between creatinine melphalan clearance (P=0.0004). Patients treated dose ⩾70 mg/m2 had...
BIBF 1120 is an oral, potent, tyrosine kinase inhibitor that simultaneously targets vascular endothelial growth factor receptors 1-3, platelet-derived α and β, fibroblast as well FLT3 Src. Currently, the molecule in phase III development for second-line non-small cell lung cancer first-line ovarian patients.This I dose-escalation study assessed safety maximum tolerated dose of continuous daily treatment with plus standard-dose docetaxel (75 mg m(-2), every 3 weeks) prednisone (5 BID)...
LBA8011 Background: Nintedanib (N) inhibits VEGFRs, PDGFRs, and FGFRs. LUME Lung 1 is a placebo (P) controlled phase III trial of N + docetaxel (D) in patients (pts) with locally advanced/metastatic NSCLC progressing after first- line therapy. Methods: Stage IIIB/IV or recurrent pts (stratified by histology, ECOG PS, prior bevacizumab, brain metastases) were randomized to 200 mg bid D 75 mg/m 2 q21d (n=655) P (n=659). 1° endpoint was centrally reviewed PFS 713 events (2 sided stratified...