PharmaMar's Yondelis enters Ph II COG trial

Spanish pharmaceutical firm PharmaMar has initiated a Phase II multicenter study of Yondelis (trabectedin) in children with recurrent rhabdomyosarcoma, Ewing's sarcoma or non-rhabdomyosarcomatous soft tissue sarcomas. The study will determine a safe and tolerable dose of the agent in pediatric patients and assess the efficacy at that dose based on response rates and also establish toxicity and pharmacokinetics in this age group.

A total of 60 subjects aged 12 months to 21 years will be recruited over two years. Yondelis will be administered as an intravenous infusion for 24 hours every three weeks. The study is being carried out by the Children's Oncology Group at centers in the USA and Canada. COG is an international research group with more than 200 hospitals that treat children with cancer in North America, Australia, and Switzerland. The study is being managed by the drug's co-development partner, US health care major Johnson & Johnson.

The COG carried out a Phase I clinical trial to determine Yondelis' dose-limiting toxicities and maximum tolerated dose in children with refractory solid tumors, establishing the recommended dose for pediatric Phase II trials, and found that Yondelis is safe in children, PharmaMar stated.