Clinical Trial Detail

The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated with an anthracycline and ifosfamide.

Genders Eligible for Study: Both

- Locally advanced or spreading liposarcoma or leiomyosarcoma that has been diagnosed through tissue analysis and is unable to be removed by surgery

- Treated with an anthracycline and ifosfamide administered either in combination or as sequential regimens

- Measurable disease at baseline in accordance with Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1

- Pathology specimens (eg, tumor blocks or unstained slides) for potential centralized pathology review and biomarker studies

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Other eligibility criteria may apply.

- Less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent

- Other malignancy within past 3 years (exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix)

- Known central nervous system metastasis

- Active liver disease, such as chronic viral hepatitis or cirrhosis

- Heart attack within 6 months before enrollment

- Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Other exclusion criteria may apply.