Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Dexamethasone

Doxorubicin

Liposomal doxorubicin

Dexamethasone acetate

Trabectedin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Alkylating Agents

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.

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

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

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.

DOXIL

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.

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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.

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.

An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

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

PFS is defined as the time between randomization and disease progression or death.

Overall survival was defined as the time between the randomization and death

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.

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.

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.

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.

PharmaMar

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Number of treated participants were analyzed for adverse events. 672 participants were randomized (337 in trabectedin + DOXIL arm and 335 in DOXIL arm), out of which 663 participants received treatment ie, 330 participants received DOXIL and 333 received trabectedin + DOXIL and were analyzed for adverse events.

30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks

Trabectedin/DOXIL

50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks

Total

Age, Continuous

Sex: Female, Male

Argentina

Australia

Belgium-Luxemburg

Brazil

Canada

Chile

France

Germany

Hong Kong

Italy

Netherlands

China

Poland

Republic Of Korea

Russia

Singapore

Spain

Sweden

Taiwan

United Kingdom

United States Of America

Region of Enrollment

Director Clinical Research Medical Leader

All Measurable Analysis Participants: All randomized participants who had measurable disease at baseline as assessed by the independent radiology review. Measurable disease is defined as having at least 1 lesion measured with a diameter of ≥20 mm using conventional techniques or of ≥10 mm using a spiral computerized tomography scan.

Progression-Free Survival (PFS): Independent Radiologist Review

All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not

Overall Survival

All Randomized Analysis Participants: all participants who were randomized to this study, independent of whether they received study medication or not.

Objective Response Rate (ORR) - Independent Radiologist Review

All Responders (CR/PR) Analysis Participants: all participants who achieved CR or PR as best overall response during the study.

Duration of Response: Independent Radiologist Review

Blood samples for pharmacokinetic analysis were collected from 86 participants of this study.

Spots Global Cancer Trial Database for advanced relapsed ovarian cancer