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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - EPO906 (Patupilone)
Treatment: Drugs - doxorubicin

Experimental: Patupilone -

Active Comparator: doxorubicin -


Treatment: Drugs: EPO906 (Patupilone)


Treatment: Drugs: doxorubicin
Intervention code [1] 0 0
Treatment: Drugs
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
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Alaska
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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
The objective of this study is to assess the safety and efficacy of patupilone compared to
pegylated liposomal doxorubicin. Additionally, this study will assess the ability of
patupilone to extend the survival time and potential beneficial effects in women who have
nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00262990
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00262990