Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00262990




Registration number
NCT00262990
Ethics application status
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
17/12/2020

Titles & IDs
Public title
Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
Scientific title
A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
Secondary ID [1] 0 0
CEPO906A2303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Peritoneal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Patupilone -

Active comparator: doxorubicin -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
Timepoint [1] 0 0
every 8 weeks
Secondary outcome [1] 0 0
To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
Timepoint [1] 0 0
End of study
Secondary outcome [2] 0 0
To determine the progression-free survival (PFS) of patients treated with patupilone
Timepoint [2] 0 0
end of study
Secondary outcome [3] 0 0
To determine the time to disease progression (TTP) of patients treated with patupilone
Timepoint [3] 0 0
end of study
Secondary outcome [4] 0 0
To determine overall best tumor response (CR, PR, SD, PD and Unknown)
Timepoint [4] 0 0
end of study
Secondary outcome [5] 0 0
To investigate the safety and tolerability of patupilone
Timepoint [5] 0 0
end of study
Secondary outcome [6] 0 0
To evaluate the pharmacokinetics (PK) of patupilone from all patients
Timepoint [6] 0 0
end of study
Secondary outcome [7] 0 0
To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events
Timepoint [7] 0 0
end of study

Eligibility
Key inclusion criteria
* 18 years of age or older
* Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
* No more than three chemotherapy regimens
* Most recent regimen must have been platinum based
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have an unresolved bowel obstruction
* Have had previous chemotherapy within 3 weeks
* Recovering from any surgery for any cause

Other protocol-defined inclusion/exclusion criteria will apply.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
829
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - Nedlands, WA
Recruitment hospital [4] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [5] 0 0
Novartis Investigative Site - St. Leonards
Recruitment hospital [6] 0 0
Novartis Investigative Site - Wodonga
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Nedlands, WA
Recruitment postcode(s) [4] 0 0
- South Brisbane
Recruitment postcode(s) [5] 0 0
- St. Leonards
Recruitment postcode(s) [6] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alaska
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Arizona
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Arkansas
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California
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Mississippi
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Missouri
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Nebraska
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New Hampshire
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North Carolina
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South Carolina
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Washington
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Wisconsin
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Canada
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British Columbia
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Canada
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Calgary
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Canada
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Montreal
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Canada
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North York
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Quebec
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Sherbrooke
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Toronto
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Odense
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Vejle
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Helsinki
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Kuopio
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Tampere
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Amboise
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France
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Bordeaux
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France
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Caen Cedex
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France
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Herblain Cedec
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France
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Greece
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Athens
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Italy
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Bologna
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Milano
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Italy
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Modena
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Italy
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Monza
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Padova
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Roma
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Torino
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Poland
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Krakow
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Cape Town
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South Africa
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Johannesburg, Gauteng
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Klerksdorp
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Port Elizabeth
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Pretoria, Guateng
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Spain
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Barcelona
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London
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Wirral
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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 not provided in https://clinicaltrials.gov/study/NCT00262990