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National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Drug: Chemotherapy Drug: Rucaparib. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :. Estimated Study Completion Date :. Drug: Chemotherapy Chemotherapy will be administered per local standard of care and regulations. Masarykuv Onkologicky Ustav, Oddeleni komplexni klinicke onkologie. Rucaparib versus chemotherapy in patients with advanced, relapsed ovarian cancer and a deleterious BRCA mutation: efficacy and safety from ARIEL4, a randomized phase 3 study.

Abstract FDA grants accelerated approval to new treatment for advanced ovarian cancer. News release. December 19, Accessed March 19, About Advertise CureToday. March 20, Study record managers: refer to the Data Element Definitions if submitting registration or results information. The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts.

Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 BRCA1 or BRCA2 mutations. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring a downstream consequence of HRD in a patient's tumor and observed clinical benefit from rucaparib treatment.

Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome tumor genomic LOH. One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known i.

PART 2 completed enrollment : Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years. Complete response CR is disappearance of all target lesions.

For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Overall Survival Part 2 of Study [ Time Frame: All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years.

Patients without a known date of death will be censored on the date the patient was last known to be alive. Steady State Trough Cmin Level Rucaparib Concentrations [ Time Frame: Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks ] Per protocol, the secondary PK endpoint, trough Cmin concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected.

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