Study design

This study was an open-label, multicentre, dose-escalating phase I study of rucaparib administered in combination with one of four different standard chemotherapeutic regimens ({"type":"clinical-trial","attrs":{"text":"NCT01009190","term_id":"NCT01009190"}}NCT01009190). Eligible patients ⩾18 years of age had a histologically or cytologically confirmed advanced solid tumour, an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, life expectancy of ⩾12 weeks, and adequate bone marrow, liver, and renal function. All BRCA testing was done locally and was not verified by the sponsor. The primary objective was to assess safety and tolerability and estimate the maximum tolerated dose (MTD) and/or select the recommended phase II dose of rucaparib in combination with chemotherapy. Secondary objectives were to characterise the pharmacokinetics (PK) and assess the antitumour activity of rucaparib when combined with chemotherapy.

The study was approved by the Research Ethics Committee for all participating institutions and conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonisation. Patients gave written informed consent before undergoing any study-related procedures.