12 results
To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remissionTo determine whether restarting of Imatinib in case of molecular relapse results in a…
Primary:- To determine the MTD and/or a recommended phase II dose (RP2D) of BYL719 when administered orally in combination with imatinib 400 mg q.d.Secondary:- Assess the safety and tolerability profile of imatinib and BYL719 administered in…
This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib
Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid secretion might be causing the decreased exposure in the patients that underwent major gastrectomy. Therefore we would like to study if the exposure to imatinib in…
The purpose of this extension is to provide continued treatment and to assess the long term safety, efficacy and tolerability of oral AEB071 plus Certican® vs. Neoral® plus Certican® in de novo renal transplant recipients. The study is a…
Primary:* Determine the maximum tolerated dose (MTD) and/or a recommended Phase II dose (RP2D) of BKM120 when administered in combination with imatinib 400 mg q.d.Secondary:* Assess the safety and tolerability profile of imatinib and BKM120…
To compare progression free survival (PFS) of nilotinib and imatinib when used as initial therapy of unresectable and/or metastatic GIST in patients either who have not received prior therapy with TKIs or who have recurrent GIST after stopping…
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…
To evaluate the CCyR rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response on imatinib.
To compare the best confirmed complete cytogenetic response (CCyR) rates within 12 months in newly diagnosed chronic phase CML subjects treated with dasatinib versus imatinib
Safety and efficacy objectives:The objective is to compare the safety and efficacy of masitinib at 6 of 7.5 mg/kg/day to imatinib at 400 or 600 mg, in patients with gastro-intestinal stromal tumour in first line medical treatment.
Primary* To compare the efficacy (Major Molecular Response, MMR, rate at 12 months) Secondary* To compare the rate of durable MMR at 24 months in patients with a MMR at 12 months* To compare the rate, time to and duration of complete cytogenetic…