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Complete title: A Randomized Controlled Study of YONDELIS® (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma Previously Treated with an Anthracycline and Ifosfamide
|Research Study Number||20110545|
|Principal Investigator||Robin Jones|
Research Study Description
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.
Eligibility Criteria (must meet the following to participate in this study)
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.
Exclusions (conditions that would prevent participation in this study)
- 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.
Sarcoma; Solid Tumors
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