26 results
Evaluation of the effect of salvage therapy with R-DHAP followed by reduced-intensity conditioning and allogeneic stem cell transplantation from a sibling or unrelated donor
Primary objectives:• To assess early mortality risk (first 30 days after start of induction therapy) of treatment with decitabine-cytarabine in elderly patients with AML or high risk myelodysplastic syndrome (IPSS >=1.5) with a high risk of…
Quizartinib selectively inhibits survival pathways that block apoptosis by inhibiting FLT3. Quizartinib inhibits proliferation of FLT3-dependent cell lines, and is effective in human leukemia tumor xenograft models of AML. Data from the Phase 1 and…
To assess and compare efficacy (complete response [CR] rate and overall survival [OS]) between SGI-110 and TC in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients * 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction…
Primary aims:1. To perform a population-based screen to estimate the exact frequency ot transient leukemia in Dutch newborns with Down syndrome2. To investigate the realtionship between transient leukemia and the occurrence of DS ML and ALL at later…
The primary objective for this study is as follows:Within the TP53 wild-type populationTo compare overall survival (OS) in patients with relapsed or refractory AML who havebeen randomized to idasanutlin in combination with cytarabine versus those…
To increase the fraction of patients with a PET-negative metabolic complete remission after second line chemotherapy with 3 courses of DHAP , each in combination with one i.v infusion of BV. This will make more patients eligible for high dose…
Primary objective:• To evaluate the safety and tolerability of single intravenous (i.v.) doses of XAB05 in healthy subjects.Secondary objective:• To characterize the plasma pharmacokinetic (PK) profile of single i.v. doses of XAB05 in healthy…
Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…
Primary objective:To investigate the pharmacokinetics (PK) of IZD174 in plasma and CSF of subjects with Parkinson*s Disease.Secondary objective:To investigate the pharmacodynamics (PD) of IZD174 in plasma of subjects with Parkinson*s Disease as…
Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…
Primary objective:• To evaluate the safety and tolerability profile of single intravenous doses of AST-004 given as a short loading intravenous infusion followed by a 6-hour continuous intravenous (IV) infusion in healthy adult subjects.Secondary…
Primary objective:* To evaluate the safety of BYON5667 eye drops.Secondary objective:* To evaluate the tolerability of BYON5667 eye drops.
Primary objective:• To investigate the effect of THB001 on the pharmacokinetics (PK) of caffeine, omeprazole and midazolam.Secondary objective:• To evaluate the safety and tolerability of THB001 co-administered with caffeine, omeprazole and…
The primary objective of this study is to confirm that the dissolution profiles of a sugar-free and sugared lozenge containing CPC/benzocaine (1.4mg/10 mg) are comparable following a single dose in healthy adult subjects.The secondary objectives of…
Part 1 SAD:Primary objective: To evaluate the safety and tolerability of single ascending doses of ANXV in healthy subjects.Secondary objective: To determine the PK profile of single ascending doses of ANXV in healthy subjects.Part 2 MAD:Primary…
Part 1 - Single Ascending Dose (SAD) Capsule Formulation:Primary objective:To investigate the safety and tolerability of single oral doses of R289 capsules in healthy subjects.Secondary objective:To characterize the pharmacokinetic (PK) profiles of…
Primary objective:To evaluate safety and tolerability, and pharmacokinetics (PK) of single ascending doses of GAL-475 in healthy volunteers.Secondary objective:To evaluate safety and tolerability, PK and PD of single doses of GAL-475 in subjects…
Part 1:Primary objective:• To evaluate the PK profile of a single oral dose of ESB1609 jetmilled Form A in plasma and compare this profile with the PK profile of ESB1609 monohydrate Form B with 30% SLS.• To compare the PK profile of different…