9 results
Primary Study Objective: To evaluate the effect of telotristat etiprate versus placebo over the double-blind portion of the study on the incidence of treatment-emergent adverse events (TEAEs)
The aim of this study is to quantify residual ER binding sites during fulvestrant therapy, compared to the tracer uptake prior to fulvestrant therapy.
In this study, plerixafor, the study drug, will be given in addition to GCSF to see if it works the same way in children as in adults.
The aim of this study is to evaluate androgen receptor (AR) and estrogen receptor (ER) expression non-invasively by means of PET imaging with the tracers 18F-FDHT and 18F-FES. To verify the PET results, the standard diagnostic biopsy will be…
Primary objectiveTo determine the feasibility of plerixafor 320 *g/kg subcutaneously to harvest a sufficient number of CD34+ peripheral blood stem cells/kg recipient body weight. Feasibilty is defined as a minimum of 2.0x10^6/kg CD34+ cells in one…
The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the change from baseline in the number of daily bowel movements (BMs) averaged over the 12-week…
To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
The primary objective of this study is to evaluate the long-term safety and tolerability of orally administered telotristat etiprate.The secondary objective is to evaluate changes in patients* quality of life (QOL) through week 84.
To demonstrate that Plerixafor is able to reduce the need for invasive mechanical ventilation or death in severe COVID-19 patients admitted in Intensive Care Unit (ICU)