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news.California-based biopharmaceutical company Telik has initiated an international phase III clinical trial that will evaluate its drug candidate Telcyta in the treatment of women with platinum refractory or resistant ovarian cancer.
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In the trial, dubbed ASSIST-5, approximately 244 women will be randomized to receive either a combination of Telcyta plus Doxil, a chemotherapeutic which is often prescribed for second line ovarian cancer treatment, or Doxil alone.
Trial endpoints include objective response rate, progression-free survival and overall survival. ASSIST-5 is based on the positive results previously reported from a multicenter phase II study which evaluated the same drug combination.
“If the trial is successful, it may offer additional treatment strategies for many patients initially treated with platinum-containing regimens,” said Michael Inouye, senior vice president of Telik’s commercial operations.
Two additional phase III trials are currently evaluating Telcyta in third line platinum refractory or resistant ovarian cancer, and a combination of Telcyta plus carboplatin versus Doxil.