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Published byHarvey Palmer Modified over 8 years ago
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1SOLO 2 - June 2015
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<8 weeks 2 Platinum sensitiverelapse C1 C2 C3 C4 C5 C6 Screening Known or unknown BRCA mutation High grade serous ovarian cancer or high grade endometrioid cancer In complete or partial response Screening Known or unknown BRCA mutation High grade serous ovarian cancer or high grade endometrioid cancer In complete or partial response Platinum based chemotherapy Maintenance Olaparib per os 300 mg/bid Olaparib per os 300 mg/bid Placebo until progression or toxicity SOLO 2 - June 2015 STRATIFICATION Response to previous platinum chemotherapy (CR or PR) Time to disease progression in the penultimate platinum based chemotherapy prior to enrolment (>6 - 12 months and >12 months) STRATIFICATION Response to previous platinum chemotherapy (CR or PR) Time to disease progression in the penultimate platinum based chemotherapy prior to enrolment (>6 - 12 months and >12 months) Objectives Primary : PFS Secondary : OS, Safety, QOL, secondary PFS, PK, somatic mutational status, efficacy of Olaparib, Olaparib exposure Randomiaation (1:2)
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SOLO 2 - June 20153 603 patients enrolled for 295 patients randomised Initial plan was 440 patients to recruit 264 patients with BRCA mutation 603 patients enrolled for 295 patients randomised Initial plan was 440 patients to recruit 264 patients with BRCA mutation
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4 SOLO 2 - June 2015
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