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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

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ClinicalTrials.gov Identifier: NCT02289950
Recruitment Status : Recruiting
First Posted : November 13, 2014
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Morphotek

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Platinum-Sensitive Ovarian Cancer in First Relapse Drug: Farletuzumab Drug: Placebo Phase 2

Detailed Description:
Subjects will be enrolled in a targeted 1:1 stratification ratio 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 19, 2015
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : September 27, 2019


Arm Intervention/treatment
Experimental: Farletuzumab
All subjects will receive a loading dose for the first 2 weeks of 10 mg/kg farletuzumab, followed by 5 mg/kg weekly farletuzumab administered intravenously (IV)
Drug: Farletuzumab
Farletuzumab will be administered intravenously (IV) weekly

Placebo Comparator: Placebo
All subjects will receive placebo weekly, administered intravenously (IV).
Drug: Placebo
Placebo will be administered intravenously (IV) weekly




Primary Outcome Measures :
  1. Progression Free Survival (PFS) based on the investigators' radiographic assessments utilizing RECIST 1.1 criteria [ Time Frame: Up to approximately 46 months ]
    PFS is defined as the time (in months) from the date of randomization to the date of the first observation of progression or date of death, whatever the cause. If progression or death is not observed for a subject, the PFS time will be censored at the date of last tumor assessment without evidence of progression prior to the date of initiation of further antitumor treatment or the cut-off date, whichever is earliest.


Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: Up to approximately 46 months ]
    Defined as the time from the date of randomization to the date of death, due to all causes. If death is not observed for a subject, the overall survival (OS) time will be censored at the last date known to be alive or the cut-off date, whichever is earliest.

  2. Length of First vs Second Platinum-Free Interval [ Time Frame: Up to approximately 46 months ]
    Length of first platinum-free interval is defined as the period of time (in months) from the date of completion of previous platinum based chemotherapy until date of first relapse, as recorded on the eCRF. The date of first relapse is the progression date based on a radiographic assessment. Similarly, length of second platinum-free interval is defined as the period of time (in months) from the date of completion of platinum based chemotherapy (last dosing date) during the study until the date of progression based on the investigator's radiographic assessment (RECIST 1.1).

  3. Tumor Response: Objective Response (OR) per RECIST 1.1 [ Time Frame: Up to approximately 46 months ]
    OR is defined as either a complete response (CR) or a partial response (PR) using RECIST 1.1 criteria. Tumor assessments performed up to the initiation of further anti-tumor treatment will be considered.

  4. Tumor Response: Time to Response (TTR) per RECIST 1.1 [ Time Frame: Up to approximately 46 months ]
    TTR is defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR).

  5. Tumor Response: Duration of Response (DR) per RECIST 1.1 [ Time Frame: Up to approximately 46 months ]
    DR is defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's radiographic assessment (RECIST 1.1), or date of death, whatever the cause.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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) 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 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 and should be randomized within 16 weeks of radiographic relapse
  8. Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD
  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
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289950


Contacts
Contact: Susan C Weil 610-423-6182 weil@morphotek.com

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Sponsors and Collaborators
Morphotek
Eisai Co., Ltd.

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT02289950     History of Changes
Other Study ID Numbers: MORAb-003-011
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Morphotek:
Ovarian Cancer in in first relapse
Platinum-Sensitive

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Recurrence
Hypersensitivity
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Immune System Diseases
Paclitaxel
Liposomal doxorubicin
Carboplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors