The primary endpoint is an estimation of progression-free survival, while secondary endpoints include objective response rate and clinical benefit rate of imetelstat when added to paclitaxel
Preliminary results in the intent-to-treat (ITT) population showed a trend favoring the ficlatuzumab/gefitinib combination in the primary endpoint of overall response rate (ORR), though results did not reach statistical significance
The trial will compare carfilzomib/lenolidomide/dexamethasone against lenolidomide and dexamethasone in 780 patients with relapsed multiple myeloma at about 200 sites, with a primary endpoint of progression-free survival and secondary endpoints including overall survival, overall response rate, duration of response, disease control rate, safety, time-to-progression and time-to-next-treatment
About 95 patients in a first or second relapse following standard therapy will be enrolled, and endpoints will include the progression rate at six months, objective response rate, overall survival and progression-free survival
Emergent BioSolutions Inc., of Rockville, Md., said it started a Phase II study of TRU-016 in combination with bendamustine in patients with relapsed chronic lymphocytic leukemia, triggering a $6 million milestone payment to Emergent by Abbott, of Abbot Park, Ill. The study is designed to compare the combination of the anti-DC37 monospecific protein therapeutic plus bendamustine to bendamustine alone in about 100 randomized patients, with a primary endpoint of overall response rate defined by
and one outside – and will enroll previously untreated follicular lymphoma patients, with the primary objectives of complete response rate and progression-free survival...Secondary objectives will include event-free survival, overall survival, overall response rate, health-related quality of life and safety
The primary efficacy endpoint for the trial is intra-cranial response rate...secondary endpoints include progression-free survival and objective tumor response rates
Clinical response rates of 93 percent, 96 percent and 88 percent for the 100 U/kg, 50 U/kg and 2100 U Rhucin doses, respectively, were observed compared with 41 percent in the placebo group
The study also showed trends in favor of TTF compared to chemotherapy in PFS6 (21.4 percent vs. 15.2 percent, respectively, p = ns) and radiological response rates (14 percent vs. 9.6 percent, respectively, p = ns
The study's primary objective is to determine the antitumor effects of Imprime PGG, an immunomodulatory drug, when used in combination with a monoclonal antibody and standard chemotherapy, based on overall response rate as assessed by RECIST criteria
Ltd., of Seoul, South Korea, said interim data from its Phase II trial in Stage III non-small-cell lung cancer (NSCLC) patients vaccinated with the telomerase peptide GV1001 after chemoradiotherapy demonstrated an 80 percent immune response rate
In a previous Phase Ib trial, once-daily oral IPI-926 and gemcitabine generated a response rate of 31 percent, compared to a historic overall response rate of less than 10 percent for gemcitabine
The primary objective is to determine the hematologic improvement-erythroid response rate, as determined by clinically significant transfusion reduction or independence
The primary endpoint of the trial is clinical response rate