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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.


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 Survival

Objective 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


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

Page last updated: August 20, 2015

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