5 results
Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…
Primary:- Estimate independently assessed PFS in subjects with relapsed or refractory MCL.Secondary:- Estimate OS.- Estimate objective response rate (ORR), independently and investigator assessed.- Estimate investigator assessed PFS.- Assess safety…
Primary Objective: * To evaluate the ability to concentrate the radiotracer within the prostate gland improving the evaluation of the primary prostate tumor. Secondary Objective(s): * To evaluate the PET/CT imaging characteristics of transcatheter,…
The primary study objective is to compare: - Per-patient detection rate of 18F-DCFPyL PET/CT versus that of 18F-FCH PET/CT. The secondary objectives are to assess: - Impact on patient treatment/management. - Per-region detection rate of 18F-DCFPyL…