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news.Ziopharm Oncology has announced that the first patient has been dosed in its international Phase II randomized controlled trial of palifosfamide in patients with soft-tissue sarcoma.
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This is a Phase II multi-center, parallel group, randomized study of palIfosfamide plus doxorubicin versus doxorubiCin in subjects with unresectable or metastatic soft-tissue sarcoma.
Approximately 100 evaluable subjects are expected to be enrolled in this multi-center trial, which is being conducted at sites in the US and Europe by several key opinion leaders in sarcoma.
This Phase II trial will evaluate the clinical benefit of palifosfamide administered with doxorubicin compared with single-agent doxorubicin in subjects diagnosed with unresectable or metastatic metastatic soft-tissue sarcoma in the front- or second-line treatment setting. The primary endpoint is assessment of the difference in progression-free survival between subjects in the two arms of the trial.
Sant Chawla, director of Sarcoma Oncology Center, Santa Monica, said: “By conducting a randomized controlled Phase II trial where the primary endpoint is progression-free survival, Ziopharm has optimized its chances of yielding positive results by aiding in the design and thereby mitigating risk for a Phase III pivotal trial to follow.”