23 results
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
This trial will determine the relative incidence of CV outcomes compared to placebo forthe TZD class as a whole, rosiglitazone (RSG), and pioglitazone (PIO) when added to thetherapeutic regimen of a person with type 2 diabetes who has additional…
The primary aim of this study will be to determine the effect of rosiglitazone on intima media thickness and calcification in patients with stage 4 and 5 CKD. The secondary end points are the effects on pulse wave velocity, blood pressure, the lipid…
To estimate the effect of rosiglitazone compared to placebo on ischemia-reperfusion injury as assessed by annexin A5 scintigraphy in the human forearm in subjects with the metabolic syndrome.
Primary objectives: To assess the ability of dabrafenib + trametinib treatment to downsize melanoma tumor masses to enable R0-resection. Secondary objectives: Recurrence free survival; time-to-next treatment, overall survival.
• To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP caused by RPE65 or LRAT gene mutations.• To evaluate duration of visual function improvement (if observed) in subjects with LCA or RP…
Primary:To assess the long-term safety of treatment with dabrafenib, trametinib or the combination.Secondary:To assess the long-term effect of treatment with dabrafenib, trametinib or the combination on general health, growth and development.To…
PRIMARY- Phase Ib: To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 regimen (RP2R) of ribociclib and trametinib in patients with solid tumors- Phase II: To assess overall response rate (ORR) with the combination of…
Primary objectives Phase I: To determine the recommended phase 2 dose (RP2D) of the lapatinib-trametinib combination in patients with KRASm NSCLC Phase II: To determine the progression free survival of the lapatinib-trametinib combination compared…
This drug-drug interaction (DDI) study is being conducted to determine if there is a pharmacokinetic (PK) interaction between trametinib and the components of combination oral contraceptives (OCs), norethindrone (NE) and ethinyl estradiol (EE).…
Primary objectives: To explore the safety, feasibility, and the immune-activating capacity of different schemes of continuous/intermittent dabrafenib+trametinib during treatment with pembrolizumab as compared to pembrolizumab monotherapySecondary…
Primary: superiority of dabrafenib and trametinib combination therapy over dabrafenib and trametinib-placebo (dabrafenib monotherapy) with respect to progression-free survival (PFS) for subjects with advanced/metastatic BRAF V600E/K mutation-…
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…
Primary: overall response rate.Secondary: progression free survival, duration of response, overall survival, safety, tolerability, pharmacokinetics (PK).
Primary objective: Response to trametinib treatment defined as a tumor volume decreases from baseline of >=20%, monitored by using volumetric MRI analysis. Secondary objectives are: patient reported outcomes of pain and disability and quality…
This study aims to demonstrate the effectiveness of dabrafenib with trametinib in pediatric patients with BRAF V600 mutant relapsed refractory HGG.This study aims to demonstrate the effectiveness of dabrafenib with trametinib compared to…
Primary: efficacy of dabrafenib and trametinib combination therapy compared to placebo with respect to overall response rate in subjects with rare BRAF V600E mutated solid tumors or hematologic malignancies.Secondary: duration of response,…
This is an open-label, multi-center, roll-over study designed to provide continued access to subjects who have previously participated in a dabrafenib and/or trametinib parent study and who have fulfilled the requirements for the primary objective,…
The main objective of this study is to study the feasibility and efficacy of neo-adjuvant treatment with BRAF/MEK inhibition to increase R0 rate of the tumor resection.
PrimaryPhase I: To assess the safety and tolerability of the investigational agents and define the MTD/RP2D(s)Phase II: To evaluate the activity of new drugs in T-ALL/T-LBL patients harboring specific alterations linked to mechanism of action of…