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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00849667




Registration number
NCT00849667
Ethics application status
Date submitted
13/02/2009
Date registered
24/02/2009
Date last updated
30/12/2022

Titles & IDs
Public title
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
Scientific title
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Secondary ID [1] 0 0
2008-005872-29
Secondary ID [2] 0 0
MORAb003-004
Universal Trial Number (UTN)
Trial acronym
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
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Farletuzumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Taxane
Treatment: Drugs - Farletuzumab-matched placebo

Active comparator: Farletuzumab (1.25 mg/kg) - Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.

Active comparator: Farletuzumab (2.5 mg/kg) - Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.

Placebo comparator: Placebo - Participants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.


Treatment: Drugs: Farletuzumab
Farletuzumab IV infusion.

Treatment: Drugs: Carboplatin
Carboplatin IV infusion.

Treatment: Drugs: Taxane
Taxane (Paclitaxel or Docetaxel) IV infusion.

Treatment: Drugs: Farletuzumab-matched placebo
Farletuzumab-matched placebo IV infusion.
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
From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)
Secondary outcome [2] 0 0
Cancer Antigen-125 (CA-125) Progression-Free Survival
Timepoint [2] 0 0
From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
Secondary outcome [3] 0 0
Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria
Timepoint [3] 0 0
From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
Secondary outcome [4] 0 0
Percentage of Participants With Length of Second Remission Greater Than First Remission
Timepoint [4] 0 0
From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)
Secondary outcome [5] 0 0
Percentage of Participants With Objective Response
Timepoint [5] 0 0
From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)
Secondary outcome [6] 0 0
Duration of Tumor Response
Timepoint [6] 0 0
From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)
Secondary outcome [7] 0 0
Time to Tumor Response (TTR)
Timepoint [7] 0 0
From the date of randomization to first documentation of objective response (up to 48 months)
Secondary outcome [8] 0 0
Percentage of Participants With Serologic Response (SR)
Timepoint [8] 0 0
Up to 48 months
Secondary outcome [9] 0 0
Duration of 50% Serologic Response
Timepoint [9] 0 0
From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)
Secondary outcome [10] 0 0
Time to 50% Serologic Response (TSR)
Timepoint [10] 0 0
From the date of randomization to first documentation of 50% SR (up to 48 months)
Secondary outcome [11] 0 0
Percentage of Participants With Clinical Benefit
Timepoint [11] 0 0
Up to 48 months
Secondary outcome [12] 0 0
Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel
Timepoint [12] 0 0
Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary outcome [13] 0 0
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel
Timepoint [13] 0 0
Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary outcome [14] 0 0
AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel
Timepoint [14] 0 0
Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary outcome [15] 0 0
T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel
Timepoint [15] 0 0
Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary outcome [16] 0 0
CL: Clearance of Total Carboplatin and Total Paclitaxel
Timepoint [16] 0 0
Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary outcome [17] 0 0
Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel
Timepoint [17] 0 0
Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
Secondary outcome [18] 0 0
Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores
Timepoint [18] 0 0
Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)

Eligibility
Key inclusion criteria
* A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
* Must have measurable disease by CT or MRI scan
* Must have relapsed radiologically with a randomization date within =6 and < 24 months of completion of first-line platinum chemotherapy
* Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
* Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
* Must be a candidate for carboplatin and taxane therapy
* Neurologic function: neuropathy (sensory and motor) =CTCAE Grade 1
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy
* Subjects who have received other therapy to treat their ovarian cancer since relapse
* Known central nervous system (CNS) tumor involvement
* Evidence of other active invasive malignancy requiring treatment in the past 5 years
* Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
* Previous treatment with MORAb-003 (farletuzumab)
* Clinical contraindications to use of a taxane

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 3
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
16/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2013
Sample size
Target
Accrual to date
Final
1100
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
The Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [5] 0 0
North Adelaide Oncology Clinical Trials - North Adelaide
Recruitment hospital [6] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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State/province [2] 0 0
Arizona
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State/province [3] 0 0
California
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Colorado
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District of Columbia
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Georgia
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Illinois
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Indiana
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Morphotek
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Eisai Europe Ltd. (United Kingdom)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.
Trial website
https://clinicaltrials.gov/study/NCT00849667
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00849667