Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Immune System Diseases

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Peritoneal Neoplasms

Carcinoma

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Carboplatin

Farletuzumab

Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).

Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Weekly Farletuzumab infusions Dose dependent on dosing group

Chemo Plus Far

Susan C. Weil, M.D.

The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.

MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent

1. to treat a CA125-only relapse, or
2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic relapse, and
3. to prolong a second response to chemotherapy.

Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy

A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse

Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).

Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who had a 50% response = \>50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).

Time to Serologic Response is defined as the time (weeks) from the date of first farletuzumab infusion to first documentation of 50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and at least twice the upper limit of normal) and then confirmed after 21 days.

Calculated as the time from the first documentation of 50% or greater reduction in CA-125 to the first documentation of serologic progression or death due to any cause. Serologic progression was defined as the first date of the CA-125 level being \>2 X ULN on two occasions.

The Overall Response Rate (ORR) will be determined by applying standard RECIST criteria to objective measures of disease, such as CT or MRI scans. Participants will be assigned to one of the categories of change in disease status, namely, "complete response" (CR), "partial response" (PR), "stable disease" (SD), or "progressive disease" (PD). ORR is defined as the percentage of participants with objective evidence of CR or PR.

PFS is defined for participants treated in Chemo Plus Far as the time (in months) from date of first dose in Chemo Plus Far until date of the first observation of progression based on first date of the CA-125 \>2 X ULN on two occasions, or date of death, whatever the cause. If progression or death is not observed for a participant, the PFS time is censored at the later date of last tumor assessment or CA125 assessment without evidence of progression prior to the date of initiation of further anti-tumor treatment.

Percentage of participants whose second remission was longer than their first remission. The length of remission will be determined for participants who attain CR or PR (or SD and investigator's assessment of clinical benefit). Prolongation of remission will be defined as a length of remission occurring on this study that is ≥ 1 day longer than the length of remission to the original therapy. The length of remission on this study (second remission) will be defined as the amount of time from the date of first CR or PR to the end of this remission.

Morphotek

Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).

Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.

Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far.

Far Only and Chemo Plus Far and Maintenance Far Only

Age, Continuous

Sex: Female, Male

American Indian or Alaska Native

Asian

Native Hawaiian or Other Pacific Islander

Black or African American

White

More than one race

Unknown or Not Reported

Hispanic

Race/Ethnicity, Customized

Susan Weil, MD

Far Only

All participants enrolled to initial farletuzumab only.

Serologic Response (Change in CA125 Level)

Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.

All participants enrolled to chemotherapy plus farletuzumab.

Serologic Response (Change in Cancer Antigen [CA-125] Level)

All participants enrolled to intial chemotherapy plus farletuzumab.

Time to Serologic Response (Change in CA-125 Level)

All participants enrolled to initial chemotherapy plus farletuzumab.

Duration of Serologic Response (CA-125)

Complete Response

Partial Response

Stable Disease

Progressive Disease

Not Evaluable

Overall Response Rate

Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.

Maintenace Far Only: farletuzumab, 100 mg/m2

Chemo Plus Far Plus Maintenance Far Only

All participants who received chemotherapy plus farletuzumab as well as those who continued on maintenance farletuzumab.

Progression-free Survival (PFS)

Percentage of Participants Who Had a Prolongation of Remission

Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.

Maintenance Far Only

Period 1

Period 2

Period 3

Nervous System Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.

Bruce Wallin, MD

Nelson Oyesiku, MD, PhD, FACS

The purpose of this study is to evaluate whether therapy with farletuzumab is effective and safe in the treatment of resectable, non-functioning pituitary adenomas.

Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are \> 1 cm in size that can cause progressive visual loss, headaches, and symptoms of pituitary dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete surgical resection of the tumor, repeat surgery and external beam radiation therapy may be performed. Previous clinical work suggests there may be a role for a folate receptor in the treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against resectable, non-functioning pituitary adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to determine if therapy with farletuzumab is effective and safe.

Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas

Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma

Central Nervous System Depressants

Other Dietary Supplements

Taxane

Benzocaine

Tannic Acid

Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.

Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.

Participants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.

Taxane (Paclitaxel or Docetaxel) IV infusion.

Farletuzumab-matched placebo IV infusion.

Farletuzumab-matched placebo

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors \[RECIST\]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).

OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.

CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (\>=) 2 multiple (\*) ULN with either event documented on two occasions or CA-125 \>=2\*nadir value with either event documented on two occasions.

PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 \>=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 \>=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 \>=two times ULN on two occasions at least one week apart.

Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.

Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.

Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.

Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.

SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.

Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).

Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.

Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.

Eisai Europe Ltd. (United Kingdom)

Participants received farletuzumab 1.25 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).

1.25 mg/kg Farletuzumab Plus Taxane and Carboplatin

Participants received farletuzumab 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).

2.5 mg/kg Farletuzumab Plus Taxane and Carboplatin

Participants received farletuzumab-matched placebo (0.9% saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).

Placebo Plus Taxane and Carboplatin

Total

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Intent-to-Treat (ITT) population included all participants randomly assigned to treatment, according to the treatment assigned by the interactive web or voice response randomization system (IWRS/IVRS).

Study termination was based on the primary analysis results for progression-free survival (PFS). Data collection and analyses of health care resource utilization were not performed due to the study being terminated early. Pharmacokinetic data was collected and analyzed for a maximum of only 7 participants in this study.

Eisai Medical Information

ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS.

Overall Survival (OS)

Cancer Antigen-125 (CA-125) Progression-Free Survival

Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria

ITT population included all participants randomly assigned to treatment, according to the treatment assigned by the IWRS/IVRS. Here "N" overall number of participants analyzed included all participants with potential for second remission greater than first remission.

Percentage of Participants With Length of Second Remission Greater Than First Remission

Percentage of Participants With Objective Response

Analysis performed on a subset of participants who had objective response.

Duration of Tumor Response

Time to Tumor Response (TTR)

Serologic response leading to normalization

50% SR (Responder)

75% SR (Responder)

SR leading to normalization (Responder)

SR Evaluable Populations included all randomized participants who received at least one dose of study drug and who had a baseline and at least one assessment during treatment, sufficient to assess the endpoint of interest.

Percentage of Participants With Serologic Response (SR)

Analysis was performed on a subset of participants who had serologic response.

Duration of 50% Serologic Response

Time to 50% Serologic Response (TSR)

Percentage of Participants With Clinical Benefit

Total Carboplatin

Total Paclitaxel

Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study.

Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel

Pharmacokinetic Analysis Set included all participants who have sufficient pharmacokinetic data to derive at least one pharmacokinetic parameter. Pharmacokinetic data was collected and analyzed only for a maximum of 7 participants in this study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure. Here "number of participants analyzed" signifies participants who were analyzed for this outcome measure for given categories.

AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel

T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel

CL: Clearance of Total Carboplatin and Total Paclitaxel

Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel

Cycle 3

Cycle 6

Cycle 12

Participants received farletuzumab 1.25 or 2.5 mg/kg as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve at AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC (mg\*min/mL)\*(GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).

All Participants: Farletuzumab

The population comprised of all evaluable participants who received at least one dose of farletuzumab or placebo, with study treatment assignment designated according to the IWRS/IVRS, and who completed a baseline FACT-O assessment and at least one follow-up FACT-O assessment during the study. Here "overall number of participants analyzed" signifies participants who were analyzed for this outcome measure.

Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores

Participants received farletuzumab 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion, weekly followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve area under curve (AUC) 5 or 6 milligram per minute per milliliter (mg/min/mL) (carboplatin dose \[milligram {mg}\] = Target AUC \[mg\*min/mL\]\*glomerular filtration rate \[GFR\] milliliter per minute \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).

Participants received farletuzumab-matched placebo (0.9 percent \[%\] saline) as an IV infusion, weekly followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]) as IV infusion and carboplatin dose to achieve AUC 5 or 6 mg/min/mL (carboplatin dose \[mg\] = Target AUC \[mg\*min/mL\]\*GFR \[mL/min\] + 25), administered as IV infusion on Day 1 of each 21-day cycle for 6 cycles in combination therapy. Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo as IV infusion, weekly until disease progression, unacceptable toxicity, intercurrent illness, participant or physician requested discontinuation, or investigator's judgement to discontinue treatment (up to maximum 46 cycles-each cycle 21 days).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of MORAb-003 in Women With Ovarian Cancer Who Have Relapsed After Platinum-Based Chemotherapy	NCT00318370	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...	Farletuzumab Chemo Plus Far	18 Years -	Morphotek
Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas	NCT01203618	Resectable, Non...	Farletuzumab	18 Years -	Morphotek
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse	NCT00849667	Ovarian Cancer	Farletuzumab Carboplatin Taxane Farletuzumab-ma...	18 Years -	Morphotek

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