Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Brief Summary: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of niraparib as maintenance in platinum sensitive ovarian cancer patients who have either gBRCAmut or a tumor with high-grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent. Niraparib is an orally active PARP inhibitor. Niraparib or placebo (in a 2:1 ratio) will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by the Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI), European Quality of Life scale, 5-Dimensions (EQ-5D), and a neuropathy questionnaire. Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

The primary objective of this study is to evaluate efficacy of niraparib as maintenance therapy in patients who have platinum sensitive ovarian cancer as assessed by the prolongation of progression free survival (PFS).


Options:
A: Arm Label: Niraparib; Type: ACTIVE_COMPARATOR; Interventions: Drug: Active comparator: Niraparib | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Active comparator: Niraparib; Assigned to Arm(s): Niraparib | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
B: Arm Label: KU-0059436 (AZD2281) 100 mg BID; Type: EXPERIMENTAL; Interventions: Drug: KU-0059436 (AZD2281)(PARP inhibitor) | Arm Label: KU-0059436 (AZD2281) 400 mg BID; Type: EXPERIMENTAL; Interventions: Drug: KU-0059436 (AZD2281)(PARP inhibitor) | Intervention Type: DRUG; Name: KU-0059436 (AZD2281)(PARP inhibitor); Assigned to Arm(s): KU-0059436 (AZD2281) 100 mg BID | Intervention Type: DRUG; Name: KU-0059436 (AZD2281)(PARP inhibitor); Assigned to Arm(s): KU-0059436 (AZD2281) 400 mg BID
C: Arm Label: Arm I (cediranib maleate and olaparib); Type: EXPERIMENTAL; Interventions: Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Drug: Cediranib Maleate, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Olaparib | Arm Label: Arm II (olaparib); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Echocardiography Test, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Olaparib | Intervention Type: PROCEDURE; Name: Biopsy Procedure; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib) | Intervention Type: PROCEDURE; Name: Biospecimen Collection; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib) | Intervention Type: DRUG; Name: Cediranib Maleate; Assigned to Arm(s): Arm I (cediranib maleate and olaparib) | Intervention Type: PROCEDURE; Name: Computed Tomography; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib) | Intervention Type: PROCEDURE; Name: Echocardiography Test; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib) | Intervention Type: PROCEDURE; Name: Magnetic Resonance Imaging; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib) | Intervention Type: PROCEDURE; Name: Multigated Acquisition Scan; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib) | Intervention Type: DRUG; Name: Olaparib; Assigned to Arm(s): Arm I (cediranib maleate and olaparib), Arm II (olaparib)
D: Arm Label: KU-0059436; Type: EXPERIMENTAL; Interventions: Drug: KU-0059436 (AZD2281)(PARP inhibitor) | Intervention Type: DRUG; Name: KU-0059436 (AZD2281)(PARP inhibitor); Assigned to Arm(s): KU-0059436

Answer: A