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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00849667
Ethics application status
Date submitted
13/02/2009
Date registered
20/02/2009
Date last updated
25/06/2015

Titles & IDs
Public title
Efficacy and Safety of MORAb-003 in Subjects 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 MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Secondary ID [1] 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
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 - MORAb-003 (farletuzumab)
Treatment: Drugs - MORAb-003 (farletuzumab)
Treatment: Drugs - 0.9% Saline
Treatment: Drugs - MORAb-003 (farletuzumab)
Treatment: Drugs - MORAb-003 (farletuzumab)
Treatment: Drugs - 0.9% Saline

Active Comparator: 1 - Carboplatin and taxane with MORAb-003 1.25 mg/kg

Active Comparator: 2 - Carboplatin and taxane with MORAb-003 2.5 mg/kg

Placebo Comparator: 3 - Carboplatin and taxane with Placebo

Active Comparator: 1 - Carboplatin and taxane with MORAb-003 1.25 mg/kg

Active Comparator: 2 - Carboplatin and taxane with MORAb-003 2.5 mg/kg

Placebo Comparator: 3 - Carboplatin and taxane with Placebo


Treatment: Drugs: MORAb-003 (farletuzumab)
MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

Treatment: Drugs: MORAb-003 (farletuzumab)
MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

Treatment: Drugs: 0.9% Saline
0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

Treatment: Drugs: MORAb-003 (farletuzumab)
MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

Treatment: Drugs: MORAb-003 (farletuzumab)
MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

Treatment: Drugs: 0.9% Saline
0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.

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

Outcomes
Primary outcome [1] 0 0
Progression-free survival using by RECIST
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
Progression-free survival using by RECIST
Timepoint [2] 0 0
3 years
Secondary outcome [1] 0 0
Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy.
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy.
Timepoint [2] 0 0
3 years

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
Gender
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
Completed
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,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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Indiana
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Israel
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Reggio Emilia
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Kawasaki
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Kumamoto
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Kure
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Wolverhampton

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

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/show/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
Other publications