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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
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)
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
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)
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
Accrual to date
Final
415
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
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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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United States of America
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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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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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United States of America
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Pennsylvania
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South Carolina
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United States of America
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Texas
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Utah
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United States of America
State/province [20] 0 0
Virginia
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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
State/province [24] 0 0
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
Country [32] 0 0
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
Trial website
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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00738699