13 results
- The studymedication in this clinical study was developed for long-term use in patients with endometriosis associated pelvic pain to release the pain and to avoid to otherwise necessary operation.Primary objective-To assess the dose-response…
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: To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated PBPK and pop PK approaches
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…
Primary:To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of patients that are in Major Molecular Response at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within…
Progression free survival
The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria
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
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 assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.
The primary objectives of the study are to:Determine the OBD(s) and RP2D's) of BMF-219 monotherapy administered daily based on evaluation of all available PK/ PD, target engagement, safety, and tolerability data. Note that the OBD and RP2D may…