An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer
Intervention: Trabectedin (Drug); DOXIL (Drug); Dexamethasone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression-Free Survival (PFS): Independent Radiologist Review
Secondary outcome: Overall SurvivalObjective Response Rate (ORR) - Independent Radiologist Review Duration of Response: Independent Radiologist Review Median Area Under Curve (AUC) of Trabectedin. Median Maximum Plasma Concentration (Cmax) of Trabectedin.
Detailed description:
This is a multicenter, open-label (all people know the identity of the intervention),
randomized (study medication is assigned by chance), Phase 3 study comparing the combination
of trabectedin + DOXIL with DOXIL monotherapy in patients with advanced ovarian cancer (who
were previously treated and for whom first-line platinum-based chemotherapy regimen has
failed). Approximately 650 patients will be randomly assigned to 1 of the treatment arms
(DOXIL and DOXIL + trabectedin) over 2 years. At the time of randomization, patients will be
stratified on the basis of platinum sensitivity of disease (sensitive or resistant) and
baseline Eastern Cooperative Oncology Group performance status score (0 to 1 or 2. Safety
will be evaluated on the basis of adverse events, clinical laboratory tests, physical
examination, vital signs assessment and cardiovascular safety assessment. An interim
analysis of overall survival will be performed in conjunction with progression-free survival
analysis during the study. Treatment will be continued until disease progression occurred or
until patients experienced a confirmed complete response for at least 2 cycles.
Continuation of treatment in select individual patients beyond this study end date will be
allowed if the investigator determined that the patient is benefiting from treatment, is
eligible to receive further therapy, and consents to treatment. If disease progression has
not occurred at treatment termination, then disease assessment will continue every 8 weeks
until there is evidence of disease progression or death, or until the clinical data cutoff
date, or until the start of first subsequent anticancer therapy, whichever is earlier.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
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
Locations and Contacts
Buenos Aires, Argentina
Mendoza, Argentina
Sante Fe, Argentina
Adelaide, Australia
Bentleigh, Australia
Douglas, Australia
St Leonards, Australia
Toorak Gardens, Australia
Edegem, Belgium
Hasselt, Belgium
Leuven, Belgium
Wilrijk, Belgium
Barretos, Brazil
Belo Horizonte, Brazil
Cerqueira Cesar, Brazil
Londrina, Brazil
Santo Andre, Brazil
Sao Paulo, Brazil
Reneca, Chile
Santiago, Chile
Beijing, China
Guangzhou, China
Hangzhou, China
Jinan, China
Shanghai, China
Chartres, France
Paris, France
Pierre Benite Cedex, France
Düsseldorf, Germany
Heidelberg, Germany
Jena, Germany
Karlsruhe, Germany
Mainz, Germany
Villingen-Schwenningen, Germany
Wilhelmshaven, Germany
Chai Wan, Hong Kong
Hong Kong, Hong Kong
Sha Tin, Hong Kong
Seoul, Korea, Republic of
Amsterdam, Netherlands
Enschede, Netherlands
Groningen, Netherlands
Maastricht, Netherlands
Gdansku, Poland
Gliwice, Poland
Krakow, Poland
Olsztyn, Poland
Poznan, Poland
Warszawa Poland, Poland
Wroclaw, Poland
Chelyabinsk, Russian Federation
Moscow N/A, Russian Federation
Moscow, Russian Federation
Obninsk, Kaluga Region, Russian Federation
Orenburg, Russian Federation
Saint Petersburg, Russian Federation
Samara, Russian Federation
St. Petersburg, Russian Federation
Singapore, Singapore
Barcelona, Spain
Girona, Spain
Guadalajara, Spain
L'Hospitalet De Llobregat, Spain
Madrid, Spain
Maranon, Spain
Valencia, Spain
Zaragoza, Spain
Göteborg, Sweden
Umeå, Sweden
Uppsala, Sweden
Kaohsiung County, Taiwan
Taipei, Taiwan
Tao-Yuan, Taiwan
Birmingham, United Kingdom
Edinburgh, United Kingdom
Leicester, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Poole, United Kingdom
Sheffield, United Kingdom
Mobile, Alabama, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Tucson, Arizona, United States
Los Angeles, California, United States
Newport Beach, California, United States
Orange, California, United States
Englewood, Colorado, United States
Stamford, Connecticut, United States
Tampa, Florida, United States
Coeur D Alene, Idaho, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Morristown, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Winston Salem, North Carolina, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Ottawa, Ontario, Canada
Portland, Oregon, United States
Pittsburgh, Pennsylvania, United States
Montreal, Quebec, Canada
Quebec City, Quebec, Canada
Greenville, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
Additional Information
Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Lisyanskaya AS, Makhson AN, Rolski J, Gorbounova VA, Ghatage P, Bidzinski M, Shen K, Ngan HY, Vergote IB, Nam JH, Park YC, Lebedinsky CA, Poveda AM. Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia FM, Pujade-Lauraine E, Park YC, Parekh TV, Poveda AM. Trabectedin plus pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer: Overall survival analysis.
Starting date: April 2005
Last updated: June 18, 2014
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