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: Olaparib and Cediranib; Type: EXPERIMENTAL; Interventions: Drug: Olaparib, Drug: Cediranib | Arm Label: Olaparib; Type: ACTIVE_COMPARATOR; Interventions: Drug: Olaparib | Intervention Type: DRUG; Name: Olaparib; Assigned to Arm(s): Olaparib, Olaparib and Cediranib | Intervention Type: DRUG; Name: Cediranib; Assigned to Arm(s): Olaparib and Cediranib
C: Arm Label: Arm I (adjuvant chemotherapy suboptimally debulked); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Procedure: Computed Tomography, Drug: Paclitaxel, Procedure: Therapeutic Conventional Surgery | Arm Label: Arm II (neoadjuvant chemotherapy); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Procedure: Computed Tomography, Drug: Paclitaxel, Procedure: Therapeutic Conventional Surgery | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm I (adjuvant chemotherapy suboptimally debulked), Arm II (neoadjuvant chemotherapy) | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm I (adjuvant chemotherapy suboptimally debulked), Arm II (neoadjuvant chemotherapy) | Intervention Type: PROCEDURE; Name: Computed Tomography; Assigned to Arm(s): Arm I (adjuvant chemotherapy suboptimally debulked), Arm II (neoadjuvant chemotherapy) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (adjuvant chemotherapy suboptimally debulked), Arm II (neoadjuvant chemotherapy) | Intervention Type: PROCEDURE; Name: Therapeutic Conventional Surgery; Assigned to Arm(s): Arm I (adjuvant chemotherapy suboptimally debulked), Arm II (neoadjuvant chemotherapy)
D: Arm Label: Arm I (placebo, paclitaxel, carboplatin); Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Placebo, Other: Quality-of-Life Assessment | Arm Label: Arm II (placebo, paclitaxel, carboplatin, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Placebo, Other: Quality-of-Life Assessment | Arm Label: Arm III (paclitaxel, carboplatin, bevacizumab); Type: EXPERIMENTAL; Interventions: Biological: Bevacizumab, Drug: Carboplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Quality-of-Life Assessment | Intervention Type: BIOLOGICAL; Name: Bevacizumab; Assigned to Arm(s): Arm II (placebo, paclitaxel, carboplatin, bevacizumab), Arm III (paclitaxel, carboplatin, bevacizumab) | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm I (placebo, paclitaxel, carboplatin), Arm II (placebo, paclitaxel, carboplatin, bevacizumab), Arm III (paclitaxel, carboplatin, bevacizumab) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (placebo, paclitaxel, carboplatin), Arm II (placebo, paclitaxel, carboplatin, bevacizumab), Arm III (paclitaxel, carboplatin, bevacizumab) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (placebo, paclitaxel, carboplatin), Arm II (placebo, paclitaxel, carboplatin, bevacizumab), Arm III (paclitaxel, carboplatin, bevacizumab) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm I (placebo, paclitaxel, carboplatin), Arm II (placebo, paclitaxel, carboplatin, bevacizumab) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (placebo, paclitaxel, carboplatin), Arm II (placebo, paclitaxel, carboplatin, bevacizumab), Arm III (paclitaxel, carboplatin, bevacizumab)

Answer: A