The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) patients
The study, dubbed STOP-TBI, is a randomized, dose-escalation study designed to test a single intravenous administration of Oxycyte, a nonpyrogenic perfluoro(t-butycyclohexane) emulsion product, in conjunction with supplemental oxygen
The study is an open-label, multiple-dose, dose-escalation study that will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell or diffuse large B-cell lymphoma patients
The dose-escalation trial will enroll about 56 healthy volunteers and will assess safety, tolerability and pharmacokinetics of both single and multiple doses
A Phase I, single-agent, dose-escalation study to test intravenous formulation of the drug in patients with metastatic or unresectable advanced solid cancers is being finalized
The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors
The open-label, dose escalation study will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who failed previous treatments
The dose-escalation and expansion study is designed to test safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy, as well as assess a predictive biomarker-based patient selection approach...The sequential dose-escalation phase of the trial will enroll up to 40 patients in four cohorts with dosing ranging from 1.5 mcg/kg to 18 mcg/kg
All primary study objectives were achieved in the randomized, double-blind, placebo-controlled dose-escalation trial assessing the safety, tolerability and pharmacokinetics of POL7080 in 52 healthy male volunteers
Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said its Phase III trial of Ampion for the treatment of osteoarthritis of the knee will include a dose-escalation run-in study as recommended by the FDA
The open-label, dose-escalation trial was conducted in 52 men with hormone-refractory prostate cancer that had progressed despite prior treatment with taxane-based chemotherapy regimens
Dose escalation will continue as planned to the 1,200-mg dose cohort...Following successful completion of the dose-escalation component of the study, an additional expansion cohort may be added at the highest dose of 1,200 mg
In Phase Ib, the trial will explore dose escalation and expansion