8 results
Primary• To evaluate the progression free survival (PFS), based on independent radiologic review (IRR), of ASP8273 compared to erlotinib or gefitinib in patients with locally advanced, metastatic or unresectable stage IIIB/IV adenocarcinoma non-…
The primary objective of this study is to evaluate the disease control rate (DCR; confirmed complete response (CR) or partial response (PR), or stable disease (SD)) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.…
Primary objectives: 1) Phase Ib: To estimate the MTD or RP2D of INC280 in combination with gefitinib in NSCLC patients who have c-MET dysregulation. 2) Phase II: To estimate overall clinical activity of INC280 in combination with gefitinib in NSCLC…
The purpose of the study is to assess the safety and efficacy of repeated treatments of QUTENZA in subjects with peripheral neuropathic pain.
Primary Objective: To study which test or which combination of tests has the best predictive value at baseline level for a positive effect of the ITB test-infusion, rated by the patient on the Patient-Global Impression of Change (P-GIC). Secondary…
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
-To investigate the feasibility, applicability, safety, tolerability, and reproducibility of addition of the capsaicin-heat model and the thermal grill to the existing nociceptive pain test battery in healthy subjects.-To investigate the feasibility…
Primary objective:To demonstrate superiority of Qutenza over low-dose capsaicin control in change from baseline to Week 12 in the 24-hr average pain intensity in subjects with PSNP.Secondary objective:• To demonstrate superiority of Qutenza over low…