"For each drug – tumor combination (e.g., paxalisib in patients with lung cancer brain metastases), the study envisages an initial stage of ten patients for each subgroup (i.e., breast, lung, other). If the pre-specified response criteria are met at the interim analysis of ten patients per subgroup, the study expands that drug-tumor combination to enroll eleven additional patients, in order to seek definitive efficacy data.
The paxalisib arm has fully recruited the breast cancer cohort for the initial pre-specified interim analysis and has met the threshold for transition to the expansion stage of the study.
The initial stage of the study remains ongoing for paxalisib in lung cancer and in other tumors."
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