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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - PFS is defined as the time between randomization and disease progression or death.
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 - Overall survival was defined as the time between the randomization and death
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 - Percentage of participants who achieved complete response (CR) or partial response (PR) as best overall response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR)= greater than or equal to 30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.
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 - Duration of response was defined only for participants who had complete response or partial response as best overall response. Duration of response was calculated from the date of first documentation of response (not the confirmation) to the date of disease progression or death due to progressive disease.
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. - Median simulated area under the curve (AUC) of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil, calculated using the trapezoidal rule method. Simulations were based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (Participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.
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. - Median simulated maximum plasma concentration (Cmax) at 3 hour of a 21 day trabectedin profile of participants (of this study) administering trabectedin and doxil. The assessment of Cmax was based on a dataset created of 1000 participants using the posthoc parameter estimations, derived from the population pharmacokinetic analysis dataset of Trabectedin (participants=831, with resampling). Plasma concentration-time profiles were simulated up to 504 hour post-dosing using a rich sampling.
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
Gender
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
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)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bentleigh
Recruitment hospital [3] 0 0
- Douglas
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- St Leonards
Recruitment hospital [5] 0 0
- Toorak Gardens
Recruitment postcode(s) [1] 0 0
- Adelaide
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- 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
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Poole
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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/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
Other publications