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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/NCT00113607




Registration number
NCT00113607
Ethics application status
Date submitted
9/06/2005
Date registered
10/06/2005
Date last updated
27/06/2014

Titles & IDs
Public title
An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
Scientific title
An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer
Secondary ID [1] 0 0
ET743-OVA-301
Secondary ID [2] 0 0
CR003448
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Trabectedin
Treatment: Drugs - DOXIL
Treatment: Drugs - Dexamethasone

Experimental: DOXIL + trabectedin - Combination arm - Trabectedin + DOXIL: DOXIL 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks. patients will be premedicated with 20 mg dexamethasone or its equivalent IV infusion over 30 minutes prior to the DOXIL infusion.

Active Comparator: DOXIL - Monotherapy arm - DOXIL: 50 mg/m2 IV infusion over 90 minutes every 4 weeks.


Treatment: Drugs: Trabectedin
Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.

Treatment: Drugs: DOXIL
Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.

Treatment: Drugs: Dexamethasone
Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS): Independent Radiologist Review
Timepoint [1] 0 0
From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
From the date of randomization until the date of death, as assessed for approximately 3 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR) - Independent Radiologist Review
Timepoint [2] 0 0
From the date of randomization until the date of disease progression or death, as assessed for approximately 3 years
Secondary outcome [3] 0 0
Duration of Response: Independent Radiologist Review
Timepoint [3] 0 0
From the date of first documentation of response to the date of disease progression or death due to progressive disease, as assessed for approximately 3 years
Secondary outcome [4] 0 0
Median Area Under Curve (AUC) of Trabectedin.
Timepoint [4] 0 0
Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2
Secondary outcome [5] 0 0
Median Maximum Plasma Concentration (Cmax) of Trabectedin.
Timepoint [5] 0 0
Day 1 (Predose; 1.5 hour after start of infusion; 5 minutes, 2 hour and 6 to 20 hour after end of infusion); Day 8 (168 hour after end of infusion); and Day 15 (336 hour after end of infusion) at Cycles 1 and 2

Eligibility
Key inclusion criteria
- Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or
primary peritoneal cancer

- Prior treatment with only 1 platinum based chemotherapy regimen

- Eastern Cooperative Oncology Group status of not more than 2

- Progression more than 6 months after the start of initial chemotherapy treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with more than 1 prior chemotherapy regimen

- Progression within 6 months after starting initial chemotherapy

- Prior exposure to anthracyclines

- Unwilling or unable to have central venous catheter

- Known clinically relevant central nervous system metastasis

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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
672
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bentleigh
Recruitment hospital [3] 0 0
- Douglas
Recruitment hospital [4] 0 0
- St Leonards
Recruitment hospital [5] 0 0
- Toorak Gardens
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Bentleigh
Recruitment postcode(s) [3] 0 0
- Douglas
Recruitment postcode(s) [4] 0 0
- St Leonards
Recruitment postcode(s) [5] 0 0
- Toorak Gardens
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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Idaho
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Kentucky
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Louisiana
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Massachusetts
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Argentina
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Sante Fe
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Belgium
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Edegem
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Belgium
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Hasselt
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Belgium
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Leuven
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Wilrijk
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Brazil
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Barretos
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Belo Horizonte
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Cerqueira Cesar
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Londrina
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Santo Andre
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Brazil
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Sao Paulo
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Canada
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Alberta
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Ontario
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Quebec
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Chile
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Reneca
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Chile
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Santiago
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China
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Beijing
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China
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Guangzhou
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China
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Hangzhou
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China
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Jinan
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China
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Shanghai
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France
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Chartres
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France
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Paris
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France
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Pierre Benite Cedex
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Germany
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Düsseldorf
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Germany
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Heidelberg
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Jena
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Karlsruhe
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Mainz
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Germany
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Villingen-Schwenningen
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Germany
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Wilhelmshaven
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Chai Wan
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Sha Tin
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Korea, Republic of
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Amsterdam
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Enschede
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Groningen
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Maastricht
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Gdansku
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Gliwice
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Warszawa Poland
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Poland
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Wroclaw
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Russian Federation
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Chelyabinsk
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Russian Federation
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Moscow N/A
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Russian Federation
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Moscow
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Russian Federation
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Obninsk, Kaluga Region
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Russian Federation
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Orenburg
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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Barcelona
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Girona
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Spain
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Guadalajara
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Spain
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L'Hospitalet De Llobregat
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Spain
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Madrid
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Spain
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Maranon
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Göteborg
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Sweden
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Umeå
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Sweden
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Uppsala
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Taiwan
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Kaohsiung County
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Taiwan
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Taipei
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Taiwan
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Tao-Yuan
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United Kingdom
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Birmingham
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United Kingdom
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Edinburgh
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Poole
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United Kingdom
State/province [99] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
PharmaMar
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to compare the progression-free survival (PFS) of the combination
of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00113607
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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/NCT00113607