15 results
The primary objective of this study is to provide continued access to vemurafenib for eligible patients with BRAFV600 mutation-positive malignancy who were previously treated in an antecedent vemurafenib protocol and did not meet the protocol*s…
The primary objective of this study is to evaluate the effect of multiple oral doses of vemurafenib (960 mg BID) on the PK of a single oral dose of acenocoumarol (4 mg).The secondary objective of this study is to assess the safety and tolerability…
The aim of this study is to retrieve extra measurements by Nexfin and laboratory testing in the per- and postoperative period. Can the use of Nexfin contribute in the generation of meaningful data to get an idea of the hemodynamic state of the…
The primary objective of this trial is to evaluate the efficacy of vemurafenib using BestOverall Response Rate (BORR), as assessed by an Independent Review Committee (IRC)using RECIST, v1.1 criteria in the brain of metastatic melanoma patients with…
Primary: To evaluate the safety and tolerability of RO5185426 inpatients with metastatic melanoma (Stage IV; AJCC) harboringthe BRAF V600 mutationSecondary: To evaluate the efficacy of RO5185426 as objectiveresponse rates (ORRs) determined by the…
Primary objective:- To compare efficacy of induction vemurafenib + cobimetinib followed by ipilimumab + nivolumab (Arm A) versus upfront ipilimumab + nivolumab treatment (Arm B).Secondary Objectives- To describe duration of response and overall…
To study whether either early 18F-FDG or 18F-FLT PET is superior in detecting response to treatment with the combination of vemurafenib plus cobimetinib (GDC-0973) compared to standard response assessment with CT and to evaluate whether, and which,…
The primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery, and how this relates to postoperative complications.
The primary objectives of the study are:For Parts A through C:1. Evaluate the safety and tolerability of multiple doses of CX-072, administered as monotherapy or in combination with ipilimumab or vemurafenib to patients with metastatic or locally…
Efficacy ObjectivesThe primary efficacy objective of study GO28141 is as follows:* To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV600 mutation-positive…
This study will evaluate the efficacy, safety, and pharmacokinetics of atezo + cobi + vem compared with placebo plus cobimetinib plus vemurafenib (placebo+ cobi + vem) in patients with previously untreated, BRAFV600 mutation*positive, metastatic or…
Primary ObjectiveThe primary objective of this study is as follows:* To evaluate the efficacy of vemurafenib adjuvant treatment administered over a 52-week period in patients with completely resected BRAFV600 mutation*positive, cutaneous melanoma,…
Primary: superiority of dabrafenib and trametinib combination therapy over vemurafenib monotherapy with respect to overall survival for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.Secondary: progression free…
To determine whether treatment with LGX818 plus MEK162 prolongs progression free survival (PFS) compared with vemurafenib, and/or whether treatment with LGX818 prolongs PFS compared with vemurafenib in patients with BRAF V600 mutant locally advanced…
To demonstrate superior efficacy and non-inferior safety of the SELUTION SLR 014 DEB compared to PTA (uncoated balloon) in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.