A5083350260- Cancer therapeutics and mechanisms
- Neuroblastoma Research and Treatments
- Neutropenia and Cancer Infections
- Childhood Cancer Survivors' Quality of Life
- Colorectal Cancer Treatments and Studies
- Blood disorders and treatments
- Lung Cancer Treatments and Mutations
- Hepatocellular Carcinoma Treatment and Prognosis
- Cancer Treatment and Pharmacology
- Acute Myeloid Leukemia Research
- Sarcoma Diagnosis and Treatment
- Biosimilars and Bioanalytical Methods
- Retinoids in leukemia and cellular processes
- Bacterial Identification and Susceptibility Testing
- Cancer Immunotherapy and Biomarkers
- Fungal Infections and Studies
- Pancreatic and Hepatic Oncology Research
- Microbial Metabolic Engineering and Bioproduction
- Chronic Lymphocytic Leukemia Research
- PARP inhibition in cancer therapy
- Chemotherapy-related skin toxicity
- Acute Lymphoblastic Leukemia research
- Intraperitoneal and Appendiceal Malignancies
- Genetic factors in colorectal cancer
- Drug-Induced Ocular Toxicity
Bayer (Germany)
2016-2025
Bayer (United States)
2024
Teva Pharmaceuticals (Germany)
2012-2018
Biocrates Life Sciences (Austria)
2017-2018
Leibniz University Hannover
2002
Lindenhofspital
1995-1997
Anti-programmed cell death protein 1 antibodies plus multikinase inhibitors have shown encouraging activity in several tumour types, including colorectal cancer. This study assessed regorafenib nivolumab patients with microsatellite stable/mismatch repair-proficient metastatic cancer.This single-arm, open-label, multicentre phase 2 enrolled adults from 13 sites the USA previously treated advanced Eligible had known extended RAS and BRAF status, progression or intolerance to no more than two...
4007 Background: The optimal second-line treatment for HCC after ICI is not established. Regorafenib approved of advanced sorafenib. primary aim this study was to evaluate the activity regorafenib plus pembrolizumab in patients with who progressed on only one prior regimen. Methods: Patients aged ≥18 years, CP Class A, BCLC stage B or C, and ECOG PS 0 1 received oral 90 mg once daily 3 weeks (wk) on/1 wk off i.v. 400 every 6 wk. dose could be escalated 120 first 4-wk cycle if tolerated....
635 Background: The optimal treatment for patients (pts) with advanced HCC who progress on an ICI-containing regimen has not been defined. In pts progressed one prior ICI regimen, regorafenib plus pembrolizumab (rego + pembro) showed modest anti-tumor activity (primary completion analysis: overall objective response rate 7.4%, all partial responses [PR]) and expected safety profile (NCT04696055; El-Khoueiry, ASCO 2024). We conducted additional exploratory analyses of tumor markers to gain...
This phase Ib study defined the safety, MTD, and recommended II dose (RP2D) of regorafenib combined with vincristine irinotecan (VI). Secondary objectives were evaluation antitumor activity pharmacokinetics (PK) irinotecan.Patients aged 6 months to <18 years relapsed/refractory solid malignancies [≥50% rhabdomyosarcoma (RMS)] received (starting 72 mg/m2/day) concomitantly or sequentially 1.5 mg/m2 on days 1 8, 50 1-5 (21-day cycle). Adverse events (AE) tumor response assessed. PK...
BackgroundThis phase 1 study evaluated safety, pharmacokinetics (PK), maximum tolerated dose (MTD), and antitumour activity of regorafenib in paediatric patients with solid tumours.Patients methodsPatients (aged 6 months to <18 years) recurrent/refractory tumours received oral once daily for 3 weeks on/1 week off. The starting (60 mg/m2) was derived from an adult physiology-based PK model scaled children; escalation followed by safety expansion the MTD cohort. Treatment-emergent adverse...
4078 Background: REG, a multikinase inhibitor, and PEMBRO, an anti-PD-1 mAb, are approved as monotherapies in advanced HCC after progression on sorafenib. This phase 1b dose-finding study investigated first-line REG plus PEMBRO HCC. Methods: Patients (pts) the first cohort received starting dose of 120 mg/day orally for 3 weeks (wks) on/1 wk off, which could be escalated (160 mg) or reduced (80 later cohorts, fixed 200 mg IV every wks. Due to high modification rate cohort, exploratory 80 was...
e13548 Background: Lipegfilgrastim is a once-per-cycle fixed-dose glycoPEGylated granulocyte-colony stimulating factor (G-CSF) under development for the prevention of severe neutropenia in cancer patients receiving chemotherapy (CTx). PEGylation molecule extends its half-life body, requiring less frequent dosing and allowing administration G-CSF once per CTx cycle, making treatment potentially expensive enhancing patient compliance safety. Briefly, traditional methods use chemical...
10507 Background: In pediatric patients with solid tumors, regorafenib demonstrated acceptable tolerability and preliminary anti-tumor activity. This phase 1 study evaluated in combination vincristine/irinotecan rhabdomyosarcoma (RMS) other tumors. Methods: Patients relapsed/refractory tumors received intravenous vincristine (1.5 mg/m 2 , Days 8) irinotecan (50 /day, 1–5) plus once-daily oral (patients 6– < 24 months: 60 escalating to 65 ; 2– 18 years: 72 82 ) on either 1–14 (concomitant...
Plasma amino acid level changes occur in mild, moderate and severe stages of liver injury human patients. In animal models, however, data are mainly restricted to models rats. Here we present the characterization a rat model dysfunction secondary alpha-napthylisothiocyanate (ANIT)-induced cholestasis. Rats treated with 30 mg/kg/day ANIT for 3 weeks exhibited time-dependent increase plasma alanine aminotransferase (ALT), aspartate (AST) bilirubin levels decrease albumin concentration....
Abstract Objective The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use lipegfilgrastim (Lonquex ® ), a glycopegylated granulocyte colony‐stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy routine clinical practice. primary objective incidence severe neutropenia, febrile neutropenia (FN), neutropenia‐associated complications. Method national, multicenter, NIS. Results Here, we...
The objective of this study was to estimate the net cost arsenic trioxide (ATO) added all-trans retinoic acid (ATRA) compared ATRA plus chemotherapy when used in first-line acute promyelocytic leukemia (APL) treatment for low intermediate risk patients from perspective overall Italian healthcare systemA Markov model developed with 3 health states: stable disease, disease event and death. Each month, could move or die either state. After a event, discontinued initial switched other regimen as...
10542 Background: Regorafenib, a multikinase inhibitor targeting VEGFR1-3, PDGFR, TIE-2, RET, c-KIT, is approved for the treatment of adults with advanced CRC and GIST. This study assessed its safety, PK, maximum tolerated/recommended phase 2 dose (MTD/RP2D) in pediatric patients. The was run ITCC sites. Methods: Patients 6 months to < 18 years histologically confirmed recurrent/refractory solid tumors received tablets or granulates QD first 21 days each 28-day cycle. Starting 60 mg/m2 based...
323 Background: In a phase Ib study, REG 120 mg/day plus PEMBRO for first-line treatment of advanced HCC showed no unexpected safety signals and encouraging anti-tumor activity. At the maximum tolerated dose (MTD) (120 mg/day), approximately three-quarters patients (pts) had reduction or interruption due to treatment-emergent adverse event (TEAE). Here, we present preliminary data 80 cohort. Methods: This is an ongoing, dose-finding study in pts who prior systemic therapy. first cohort,...