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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00738699
Registration number
NCT00738699
Ethics application status
Date submitted
18/08/2008
Date registered
20/08/2008
Date last updated
30/03/2017
Titles & IDs
Public title
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
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Scientific title
A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab) in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer
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Secondary ID [1]
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MORAb003-003PR
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Universal Trial Number (UTN)
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Trial acronym
FAR-122
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MORAb-003 (farletuzumab)
Treatment: Drugs - 0.9% Saline
Treatment: Drugs - Paclitaxel
Active Comparator: 1 - MORAb-003 (Farletuzumab) Plus Paclitaxel
Placebo Comparator: 2 - Placebo Plus Paclitaxel
Treatment: Drugs: MORAb-003 (farletuzumab)
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
Treatment: Drugs: 0.9% Saline
Placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
Treatment: Drugs: Paclitaxel
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, 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).
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Timepoint [1]
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Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS was defined as the time (in months) from the date of randomization to the date of death, whatever the 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.
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Timepoint [2]
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Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
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Secondary outcome [1]
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Best Overall Response
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Assessment method [1]
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BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
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Timepoint [1]
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Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
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Secondary outcome [2]
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Time to Tumor Response (TTR)
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Assessment method [2]
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TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
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Timepoint [2]
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Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
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Eligibility
Key inclusion criteria
- Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and
fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks
prior to study entry
- Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically
within 6 months of most recent platinum-containing chemotherapy. At least one of the
lines of chemotherapy must have included a taxane.
- Must have been treated with debulking surgery and at least one line platinum-based
chemotherapy;
- Subjects may have received up to four additional lines of chemotherapy after they
developed platinum-resistance.
- Subjects must be candidate for repeat paclitaxel treatment
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Minimum age
18
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Maximum age
99
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Clinical contraindications to use of paclitaxel, which include:
1. persistent Grade 2 or greater peripheral neuropathy
2. prior hypersensitivity reaction that persisted despite rechallenge with or
without desensitization or resulted in bronchospasm or hemodynamic instability or
was at least Grade 2 and resulted in medication discontinuation
- Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline
carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that
has been surgically resected is acceptable provided the subject did
- Prior radiation therapy is excluded with the exception that it is allowable only if
measurable disease for ovarian cancer is completely outside the radiation portal
- Known allergic reaction to a prior monoclonal antibody therapy or have any documented
human anti-human antibody (HAHA).
- Previous treatment with MORAb-003 (farletuzumab).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
415
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Westmead Hospital - Westmead
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Royal Brisbane & Women's Hospital - Herston
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The Burnside War Memorial Hospital, Inc. - Toorak Gardens
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Monash Medical Centre - East Bentleigh
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Mercy Hospital for Women - Heidelburg
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The Royal Women's Hospital - Parkville
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Sir Charles Gairdner Hospital - Nedlands
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St. John of God Hospital - Subiaco
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2031 - Randwick
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2145 - Westmead
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4029 - Herston
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5064 - Toorak Gardens
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Recruitment postcode(s) [5]
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3165 - East Bentleigh
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Recruitment postcode(s) [6]
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3084 - Heidelburg
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Recruitment postcode(s) [7]
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3052 - Parkville
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment postcode(s) [9]
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6008 - Subiaco
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Recruitment outside Australia
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United States of America
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Alabama
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Morphotek
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Address
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Ethics approval
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Summary
Brief summary
The study is being conducted to find out if paclitaxel works better when given together with
an experimental drug called MORAb-003 (farletuzumab) or alone in patients with
platinum-resistant or refractory relapsed ovarian cancer
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00738699
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00738699
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