ZK-EPO is a novel epothilone that was strategically designed to overcome the limitations associated with other microtubule stabilizing agents by combining high potency with a wide therapeutic window.
The single arm, open-label phase II metastatic breast cancer trial will recruit patients in about 20 study sites across the US and Canada. ZK-EPO will be administered every three weeks to patients who had up to three previous lines of chemotherapy. Patients will have had previous taxane and anthracycline-based chemotherapy, whether in combination or as separate regimens.
The second phase I/II trial, with ZK-EPO in combination with carboplatin, will seek to enroll patients with recurrent ovarian cancer after first-line treatment with platinum-based chemotherapy. This study will be conducted in up to 30 centers across the US and Canada.
Two further studies to be conducted in North America are under preparation and are likely to be initiated in the second half of 2006.
Additional phase II trials are currently underway in Europe, evaluating ZK-EPO in non-small-cell lung, small-cell lung, breast and ovarian cancers. A small-cell lung cancer trial was recently initiated in Germany, in which ZK-EPO will be tested as first-line monotherapy. A phase I study in patients with various solid tumors is also ongoing in Japan.