6 results
The objective is to define the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is…
To investigate the efficacy, safety, and pharmacokinetics of volasertib in combination with low-dose cytarabine versus investigator*s choice of anti-leukemic treatment in patients with relapsed or refractory acute myeloid leukemia with no…
The objective of this pivotal study is to assess the long-term safety, tolerability, pharmacokinetics and pharmacodynamics of RP103 in pediatric and adult patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support…
Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…
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…
The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…