Telik has announced the initiation of ASSIST-5, an international Phase III clinical trial that will compare treatment with the combination of Telcyta and Doxil to treatment with Doxil alone in women with platinum refractory or resistant ovarian cancer.
The company plans to enroll approximately 244 women with 122 randomized to each treatment arm. 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 of the combination of Telcyta plus Doxil in platinum refractory or resistant ovarian cancer.