A5044350575- Colorectal Cancer Treatments and Studies
- Melanoma and MAPK Pathways
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Cancer Treatment and Pharmacology
- HER2/EGFR in Cancer Research
- Complementary and Alternative Medicine Studies
- Monoclonal and Polyclonal Antibodies Research
- Lung Cancer Treatments and Mutations
- Drug Transport and Resistance Mechanisms
- Advanced Breast Cancer Therapies
- CAR-T cell therapy research
- Pancreatic and Hepatic Oncology Research
- Respiratory and Cough-Related Research
- Ovarian cancer diagnosis and treatment
- PI3K/AKT/mTOR signaling in cancer
- Nausea and vomiting management
- Antibiotics Pharmacokinetics and Efficacy
- Gallbladder and Bile Duct Disorders
- Pharmacological Effects and Toxicity Studies
Pfizer (United States)
2023-2025
Array BioPharma (United States)
2013-2018
Abstract Purpose: ONT-380 (ARRY-380) is a potent and selective oral HER2 inhibitor. This Phase I study determined the MTD, pharmacokinetics (PK) antitumor activity of in HER2-positive advanced solid tumors, with an expansion cohort patients HER2+ MBC. Experimental Design: was administered twice daily (BID) continuous 28-day cycles. After modified 3+3 dose-escalation design enrolled. PK properties metabolite were determined. Response evaluated by Evaluation Criteria Solid Tumors (RECIST)....
Binimetinib (MEK162; ARRY-438162) is a potent and selective oral MEK 1/2 inhibitor. This phase 1 study determined the maximum tolerated dose (MTD), safety, pharmacokinetic pharmacodynamic profiles, preliminary anti-tumour activity of binimetinib in patients with advanced solid tumours, expansion cohorts biliary cancer or KRAS- BRAF-mutant colorectal cancer. was administered twice daily. Expansion were enroled after MTD determination following 3+3 dose-escalation design. Pharmacokinetic...
ABSTRACT Binimetinib is a MEK1/2 inhibitor particularly active in cells harboring activating mutations the MAP kinase pathway, especially BRAF and NRAS . Binimetinib, combination with encorafenib, has received marketing approval several jurisdictions for treatment of patients V600E or V600K mutant melanoma. The absorption, distribution, metabolism, excretion binimetinib were evaluated by administering carbon 14–labeled 45 mg dose (containing 40 μCi radiolabeled material) to 6 healthy male...
Summary Background The pharmacokinetics of polyethylene glycol 3350 (PEG‐3350) have not been fully described because lack a sufficiently sensitive analytical method. Aim To describe the PEG‐3350 in humans. Methods A highly sensitive, high performance liquid chromatography with mass spectrometry (HPLC/MS/MS) method was developed for urine, plasma and faeces quantification limits 30 ng/mL, 100 ng/mL 500 μg/g respectively. Noncompartmental methods were used effects gender, age, renal status...
Abstract Encorafenib is a potent and selective ATP competitive inhibitor of BRAF V600–mutant kinase approved for patients with BRAF‐mutant melanoma colorectal cancer. mainly metabolized by cytochrome P450 (CYP) 3A4 in vitro may be susceptible to drug–drug interactions when co‐administered CYP3A inhibitors or inducers. The primary objective was assess the impact strong posaconazole (part 1) moderate P‐gp diltiazem 2) on encorafenib pharmacokinetics healthy volunteers following single 50‐mg...
5516 Background: Ovarian cancer is associated with key genetic alterations, including those that lead to activation of the RAS/RAF/MEK/ERK pathway. Binimetinib (BINI) a potent, selective, allosteric inhibitor MEK1/2. This study determined recommended phase II dose (RP2D) BINI administered on 2 dosing schedules in combination weekly paclitaxel (PAC) and assessed safety, pharmacokinetics (PK) preliminary antitumor activity female patients (pts) platinum-resistant epithelial ovarian, fallopian...
Abstract Background: Overexpression of HER2 occurs in ~25% breast cancers. Despite the treatment successes achieved to date, improved clinical outcomes remain needed, including prevention and CNS metastases. Small-molecule inhibitors may have advantage being able treat systemic disease simultaneously, particularly if used combination with antibody-based therapy. However, currently available small molecules also target EGFR, associated use limiting toxicities. Therefore, a specific...
8622 Background: Zensana ondansetron oral spray (ZSN) is the first 5-HT 3 antagonist to deliver ondansetron, most commonly prescribed anti-emetic for chemotherapy induced nausea and vomiting (CINV) through cavity. ZSN achieves therapeutic drug levels by delivering small droplets of concentrated solution over mucosa, which has a rich blood supply been shown be an alternative delivery route. may offer certain advantages patients experiencing CINV who have difficulty swallowing holding down...