Efficacy and Safety of Trabectedin (Yondelis®) in Patients With Advanced Soft Tissue Sarcoma

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and safety of trabectedin in real-life practice, routinely used for the management of advanced sarcoma after failure of anthracyclines and ifosfamide or patients unsuited to receive these drugs in Germany.

Trabectedin is indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar, Spain
• Treatments: Trabectedin

Criteria

Inclusion Criteria:

• Patients must comply with all of the following criteria in order to be enrolled into the study:

• Histologically diagnosed advanced STS

• Female or male aged 18 years or above

• Signed written informed consent

• Suitable to undergo treatment with trabectedin according to SmPC

• Progress after therapy with anthracyclines and ifosfamide has failed, or if patients are unsuited to receive these agents

Exclusion Criteria:

• Patients presenting contraindications for the use of trabectedin as defined in the SmPC will be excluded from participating in the study.