This regimen achieved a complete response rate of 19 percent and an overall response rate of 97 percent, with estimated progression-free survival at 24 months of 93 percent
The primary endpoint is overall survival, with secondary endpoints evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells
The primary endpoints are safety and tolerability, with secondary endpoints including the pharmacokinetic profile of the drug and an efficacy evaluation as assessed by various parameters, such as response rate as measured by bone marrow biopsy
Array BioPharma Inc., of Boulder, Colo., reported clinical data at the International Myeloma Workshop in Kyoto, Japan, showing that ARRY-520, a selective KSP inhibitor, demonstrated single-agent activity in heavily pretreated patients with relapsed or refractory multiple myeloma, with 19 months median overall survival and a 16 percent overall response rate...Further data presented showed that patients with normal levels of alpha-1-acid glycoprotein (AAG) had a longer median overall survival (20.2
Study endpoints include progression-free survival, objective response rate, median overall survival and evaluation of pharmacodynamics tumor markers, in addition to safety
single-arm Phase II trial (REO 021) of intravenous Reolysin in combination with carboplatin and paclitaxel met the primary statistical endpoint of objective tumor response rate in squamous cell carcinoma of the lung (SCCLC
The recommendation followed a planned review of safety data from 200 patients in all four arms and sustained viral response rates four weeks (SVR4) after completion of therapy from 100 patients
The study also will assess secondary measures of clinical benefit, including progression-free survival, objective response rate and overall survival at six months and 12 months...The trial will measure on-treatment antiviral responses and sustained virologic response rates
The primary endpoint is rate of progression-free survival at 16 weeks, with secondary endpoints of objective response rate, duration of response and evaluation of pharmacodynamic tumor markers
The primary endpoint of the trial is progression-free survival, while secondary endpoints include response rate, overall survival and RAR beta expression, a potential biomarker for responders
Gilead Sciences Inc., of Foster City, Calif., said top-line results from a Phase III (FUSION) study of sofosbuvir plus ribavirin in genotype 2 or 3 chronic hepatitis C virus met its primary efficacy endpoint of superiority compared to a historic control sustained virologic response rate of 25 percent...Persistent separation in the survival curves was observed with response rates and progression-free survival also favoring the 3-mg/kg bavituximab arm
Peregrine Pharmaceuticals Inc., of Tustin, Calif., reported that its 70-patient, open-label, randomized Phase II trial of bavituximab in combination with gemcitabine in previously untreated, advanced Stage IV pancreatic cancer resulted in more than a doubling of overall response rates and an improvement in overall survival (OS) compared with gemcitabine alone as the control arm...Patients treated with a combination of bavituximab and gemcitabine had a 28 percent tumor response rate compared to 13
The open-label, single-arm study will enroll about 37 patients after failure of second-line therapy, with a primary endpoint of overall response rate and secondary endpoints including progression-free survival, overall survival, median duration of response and safety
The first trial in aggressive B-cell lymphomas showed that patients had an overall response rate of 98 percent, and one-year progression-free survival of 73 percent...The Phase I/II trial showed that patients with follicular lymphoma had an overall response rate of 83 percent and one-year progression-free survival of 67 percent...A final Phase II trial in indolent non-Hodgkin's lymphoma showed an overall response rate of 90 percent
Inovio Pharmaceuticals Inc., of Blue Bell, Pa., reported interim Phase I data showing that a single dose of its H1N1 universal SynCon flu vaccine followed with a dose of a seasonal flu vaccine generated protective immune responses in 40 percent of trial subjects, compared with a 20 percent response rate in elderly patients who received the seasonal flu vaccine alone
This regimen achieved a complete response rate of 19 percent and an overall response rate of 97 percent, with estimated progression-free survival at 24 months of 93 percent