12 results
The primary objective of this study is to compare Arm 1 with Arm 2 with regard to incidence of new onset diabetes Mellitus as per the American Diabetic Association criteria at any point up to 24 weeks after kidney transplantation.The secondary…
To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…
CAEB071A2206 will assess safety, efficacy and target trough levels for optimal dosing of AEB071 combined with Certican in a CNI-free regimen in de novo renal transplant recipients. This study will combine the investigational drug AEB071 with an…
With the goal of improving kidney function and without causing an increased number of rejections, is it possible to reduce tacrolimus dosage through the use of the previously-mentioned immunosupressives after month three.
This study will evaluate the efficacy and safety of entrectinib compared with crizotinib in patients who have NSCLC harboring ROS1 gene rearrangements with and without CNS metastases. Specific objectives and corresponding endpoints for the study are…
To demonstrate that lorlatinib as a single agent (Arm A) is superior to crizotinib alone (Arm B) in prolonging Progression-Free Survival (PFS) in advanced ALK-positive NSCLC participants who are treatment naive.
Primary objectives• To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.• To determine the success rate of crizotinib and osimertinib combination…
All efficacy study objectives will be assessed in the pediatric AS study population of subjects who are 4 to 12 years old. All safety study objectives will be assessed in the pediatric AS study population of subjects who are 2 to 12 years old.…
Main objective of the trial is to determine the effect of individualizing the immunosuppressive therapy based on baseline immune-risk stratification according to 2 new biomarkers (d-sp ELISPOT IFN-γ and donor/recipient HLA Eplet Mismatch), in a…
The primary objective of this study is to evaluate the long-term safety and tolerability of OV101 in individuals with AS assessed by the incidence and severity of AEs and SAEs in subjects who are at least 2 years old.The secondary objectives of this…
Primary objective* To study the antitumor activity and safety of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or METSecondary objectives* To study the specificity of the kinase…
Primary• To determine the RP2D of crizotinib in combination with temsirolimus • To determine the safety and preliminary activity of single-agent crizotinib in ALK, MET or ROS1 positive tumors Secondary• To study the preliminary activity of…