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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
MORAb003-003PR
Universal Trial Number (UTN)
Trial acronym
FAR-122
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) - 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).
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Overall Survival (OS) - 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.
Timepoint [2] 0 0
Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Secondary outcome [1] 0 0
Best Overall Response - 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).
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Time to Tumor Response (TTR) - 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.
Timepoint [2] 0 0
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

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
Minimum age
18 Years
Maximum age
99 Years
Gender
Females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
The Burnside War Memorial Hospital, Inc. - Toorak Gardens
Recruitment hospital [5] 0 0
Monash Medical Centre - East Bentleigh
Recruitment hospital [6] 0 0
Mercy Hospital for Women - Heidelburg
Recruitment hospital [7] 0 0
The Royal Women's Hospital - Parkville
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [9] 0 0
St. John of God Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5064 - Toorak Gardens
Recruitment postcode(s) [5] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [6] 0 0
3084 - Heidelburg
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Arizona
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California
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Florida
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Georgia
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Illinois
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Indiana
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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New Jersey
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
State/province [19] 0 0
Utah
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United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Belgium
State/province [21] 0 0
Kortrijk
Country [22] 0 0
Belgium
State/province [22] 0 0
Leuven
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Belgium
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Liege
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Netherlands
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Groningen
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Netherlands
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Maastricht
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Netherlands
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Utrecht
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Spain
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Baleares
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Spain
State/province [31] 0 0
Barcelona
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Spain
State/province [32] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Morphotek
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT00738699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00738699