G3004 SOLO1 A Phase III, Randomized, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Platinum Based Chemotherapy (D0818C00001)
- To determine the efficacy of olaparib maintenance monotherapy compared toplacebo in BRCA mutated high risk advanced ovarian cancer patients who are inclinical complete response or partial response following first line platinum basedchemotherapy- To compare the effects of olaparib maintenance monotherapy compared to placeboon quality of life
- BRCA mutation- Completed 6-9 cycles of platinum based chemotherapy after initial diagnosis- Stage III or IV at diagnosis- No prior parp inhibitors- Good lab values and performance status- Must start within 8 wks of last chemotherapy treatment
Women are randomized to receive either olaparib or placebo. This is an oral drug that is taken twice daily. Each cycle is 28 days. You will have to come in as an outpatient once a month to receive a new supply. The visits are weekly during the first cycle. Treatment continues for up to 2 years.
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