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 Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer



Status:Active, not recruiting
Conditions:Ovarian Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:March 19, 2015
End Date:September 8, 2021

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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 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 Subjects With Low CA125 Platinum-Sensitive Ovarian Cancer

MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to
assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in
subjects with low CA125 platinum sensitive ovarian cancer in first relapse.

Subjects will be enrolled into 1 of 2 chemotherapy treatment arms at the investigator's
discretion: carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin
(PLD), and then randomized in a 2:1 ratio to receive weekly farletuzumab 5 mg/kg or placebo
(ie, Test Article). All subjects will receive a loading dose for the first 2 weeks of 10
mg/kg Test Article (farletuzumab or placebo). Subjects will be stratified at randomization by
individual chemotherapy treatment regimen (targeted 1:1 ratio) and platinum-free interval
following first-line therapy (6 to 12 months vs greater than 12 to 36 months).

Inclusion Criteria:

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. No cancer vaccine
therapy is allowed.

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
(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).If a patient
of childbearing potential is neither surgically sterile nor postmenopausal,
contraceptive measures must start either prior to or at Screening and continue
throughout the entire study period and for 5 months after the last dose of Test
Article is administered. Pregnant and/or lactating females are excluded

15. Subject must provide written informed consent and be willing and able to comply with
all aspects of the protocol

Exclusion Criteria:

1. Known central nervous system (CNS) tumor involvement

2. Evidence of other active invasive malignancy requiring treatment other than surgery in
the past 3 years

3. Clinically significant heart disease (eg, congestive heart failure of New York Heart
Association Class 3 or 4 angina, not well controlled by medication, or myocardial
infarction within 6 months)

4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not
adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie,
atrial fibrillation or paroxysmal supraventricular tachycardia [SVT], are eligible)

5. Active serious systemic disease, including active bacterial or fungal infection

6. Active viral hepatitis or active human immunodeficiency virus (HIV) infection.
Asymptomatic positive serology is not exclusionary.

7. Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic
corticosteroids, with the exception that low-dose corticosteroids [50 mg/day
prednisone or equivalent corticosteroid] are allowed; these should be discussed with
the Medical Monitor)

8. Known allergic reaction to a prior monoclonal antibody therapy or have any documented
Anti-Drug Antibody (ADA) response

9. Previous treatment with farletuzumab or other folate receptor targeting agents

10. For subjects being enrolled to receive PLD plus carboplatin, prior treatment with
anthracyclines or anthracenodiones

11. Breast-feeding, pregnant, or likely to become pregnant during the study

12. Any medical or other condition that, in the opinion of the investigator, would
preclude the subject's participation in a clinical study

13. Patients who have had secondary debulking surgery or any second line therapy

14. Currently enrolled in another clinical study or used any investigational drug or
device within 30 days (or 5 x half-life for investigational drugs where the half-life
is known) preceding informed consent
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