8 results
Primary: To evaluate the long-term safety and tolerability of QTI571.Secondary: * Continue to evaluate the long-term efficacy of QTI571 as measured by the change in6MWD from baseline.* Continue to assess time to clinical worsening (TTCW) endpoints…
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 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…
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
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…
• To assess the long-term bronchodilation of aclidinium/formoterol FDCs compared to individual components and placebo, when administered twice daily via inhalation to COPD patients.• To assess the benefits of aclidinium/formoterol FDCs in COPD…
Primary: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
The primary objective of this study is to compare the prevalence of delirium between oxycodone and morphine, administered by CSCI, for the treatment of pain in dying patients with a diminished renal function.The secondary objective is to compare the…