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news.Spectrum Pharmaceuticals has reached target enrollment in an open-label, randomized, controlled Phase 2 study of Belinostat in Carcinoma of Unknown Primary (CUP).
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The study enrolled patients with previously untreated CUP, were randomized into one of two treatment arms: Belinostat + carboplatin and paclitaxel (BelCaP), or carboplatin and paclitaxel (CaP).
The primary objective of the CUP study is to provide an estimate of the treatment effect of BelCaP compared to CaP in terms of progression-free survival, response rate, and overall survival in patients with CUP.
Final evaluation of overall survival is expected in the first quarter of 2012. The data from this randomized, controlled proof-of-concept study will help delineate the role of belinostat in combination with chemotherapy in the treatment of patients with CUP.
Spectrum Pharma chairman of the board of directors, president and CEO Rajesh Shrotriya said that they believe that Belinostat is an HDAC inhibitor with the potential safety advantage that allows for full-dose combination with other chemotherapeutic regimens,including carboplatin and paclitaxel, which are considered mainstays of cancer treatment.
"We look forward to the results of this trial, which Topotarget believes will be available in the third quarter of 2011," Shrotriya said.