A Study to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination With Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD) in Participants With Low CA125 Platinum-sensitive Ovarian Cancer

1. Female subjects who are at least 18 years of age at the time of informed consent

2. CA125 less than or equal to 3 x upper limit of normal (ULN) \[105 units per millilitre (U/mL)\] confirmed within 2 weeks of randomization using a centralized laboratory assay

3. A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded

4. Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen

5. Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization.

6. Must be in a first relapse and have evaluable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan, according to RECIST 1.1 (subjects with measurable disease per RECIST 1.1 or radiographically visible and evaluable disease). Subjects with only ascites or pleural effusion are excluded.

7. Must have relapsed radiographically between 6 months and 36 months of completion of first-line platinum chemotherapy

8. Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD with no medical contraindications present as outlined in the product labels for the selected regimen to be used in this study

9. Have a life expectancy of at least 6 months, as estimated by the investigator

10. Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization

11. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

12. Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)

13. Laboratory results within the 2 weeks prior to Randomization must be as follows:

* Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L

* Platelet count greater than or equal to 100 x 10\^9/L

* Hemoglobin greater than or equal to 9 g/dL

* Creatinine less than 1.5 x ULN (CTCAE Grade 1)

* Bilirubin less than 1.5 x ULN (CTCAE Grade 1)

* Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 3 x ULN

* Alkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1)

* Baseline albumin greater than or equal to Lower Limit of Normal

14. Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (eg, amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). If a patient of childbearing potential is neither surgically sterile nor postmenopausal, a highly-effective contraceptive method (ie, a method that can achieve a failure rate of less than 1 percent (%) per year when used consistently and correctly) must start either before or at Screening and continue throughout the entire study period and for 6 months after the last dose of Test Article is administered. Pregnant and/or lactating females are excluded

What this study is about