Phase 1 Trial Results of KOS-1584
The Phase 1 trial was designed to define the maximum tolerated dose, dose- limiting toxicity and recommended Phase 2 dose, and to assess early activity of KOS-1584 when administered to patients with advanced solid tumors (no standard curative therapy options). The Phase 1 trial dose schedules initially included a 1-hour weekly infusion for 3 weeks out of 4, and weekly for 2 weeks out of 3. More recently, a dose schedule of a 3-hour infusion was initiated on both weekly schedules (2 out of 3 weeks, 3 out of 4 weeks) to allow reduced Cmax (reduced peak exposure) with similar overall exposure enabling maximization of dose intensity.
A total of 50 patients have been enrolled in the Phase 1 trial. Indications of antitumor activity were observed in 32% of patients evaluable for efficacy, including,
-- 1 confirmed partial response (PR) in a patient with advanced non-small cell lung cancer (3 prior chemotherapy regimens); this patient had 44% tumor shrinkage by RECIST, and withdrew after 10 months (10 cycles) while still in PR; -- 1 patient with advanced ovarian cancer (4 prior regimens) had 40% CA125 decline and 20% shrinkage of nodal disease; -- 1 patient with advanced prostate cancer had 94% reduction in PSA and improved nodal disease after cycle 2 and was on study for 6 months (6 cycles); and -- Patients with stable disease (3 or more months) include those with head and neck, prostate, ovarian, breast, non-small cell lung, colon, pancreatic and cervical cancers.
Common drug related toxicities on the 1-hour, 3-week and 4-week schedules were similar and were predominantly gastrointestinal symptoms and fatigue.
-- On the 4-week, 1-hour infusion schedule, dose-limiting toxicity was primarily diarrhea observed at 20 and 25 mg/m2; no dose-limiting toxicity was observed at
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