Publications by authors named "Akihira Mukaiyama"
Phase 1/2 study assessing the safety and efficacy of dabrafenib and trametinib combination therapy in Japanese patients with BRAF V600 mutation-positive advanced cutaneous melanoma.
J Dermatol
April 2018
The combination of dabrafenib and trametinib demonstrated encouraging antitumor activity and tolerability, at initial analysis, in Japanese patients with BRAF V600 mutant advanced melanoma warranting further investigation. This study evaluated the safety and tolerability, pharmacokinetics (PK) and preliminary efficacy of dabrafenib 150 mg b.i.
View Article and Find Full Text PDFBackground Dabrafenib is a BRAF inhibitor that has demonstrated clinical activity with a good tolerability profile in patients with BRAF mutated metastatic melanoma. This study evaluated the safety and tolerability, pharmacokinetics and preliminary efficacy of dabrafenib in Japanese patients. Methods This phase I, open-label, dose escalation study was conducted in 12 Japanese patients with BRAF mutation positive solid tumours.
View Article and Find Full Text PDFArticle Synopsis
- - Trametinib, a MEK1/MEK2 inhibitor, was tested in a clinical study for safety and efficacy in Japanese cancer patients, with one part assessing trametinib alone and another part assessing it in combination with gemcitabine.
- - In the solo treatment phase, doses of trametinib were tolerated with some responses but did not reach maximum toxicity; the combo phase saw some responses but was complicated by serious interstitial lung disease in several patients.
- - Overall, trametinib was found to be tolerable as a single agent, but its combination with gemcitabine presented greater risks, highlighting a need for careful monitoring in this treatment approach.
Purpose: In Asian countries, paclitaxel once per week is used as second-line treatment in advanced gastric cancer, including human epidermal growth factor receptor 2 (HER2) -positive tumors. The role of anti-HER2 agents, including lapatinib, in this setting and population is unclear.
Patients And Methods: TyTAN was a two-part, parallel-group, phase III study in Asian patients.
Purpose: We conducted a phase I trial of the topoisomerase I inhibitor topotecan for the purpose of determining the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of topotecan when administered weekly to patients with advanced non-small-cell lung cancer.
Patients And Methods: Twelve patients with stage IIIB or IV disease were treated with topotecan by 30-minute intravenous infusion on days 1, 8, and 15 every 4 weeks. The dose was escalated in 2-mg/m2 increments from the starting dose of 4 mg/m2 until the MTD was reached.
Objective: The Phase I dose-escalation study was conducted to evaluate the safety and pharmacokinetics of lapatinib (GW572016), a dual ErbB-1 and -2 inhibitor, in Japanese patients with solid tumors that generally express ErbB-1 and/or overexpress ErbB-2.
Methods: Patients received oral lapatinib once daily until disease progression or in an event of unacceptable toxicity.
Results: Twenty-four patients received lapatinib at dose levels of 900, 1200, 1600 and 1800 mg/day; six subjects enrolled to each dose level.