NCT03838744

Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.

Phase 2 Randomized Trial of Trabectedin + Olaparib vs. Trabectedin in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II study in patient with advanced Soft Tissue Sarcoma (STS) patients who have already received or are not suitable, for a doxorubicin-based treatment.

Detailed description

Randomized, open-label, active-controlled, multicenter phase II clinical study. Patients will be randomly assigned in a 1:1 ratio to receive trabectedin 1.1 mg/m2 24-hour intravenous continuous infusion every 3 weeks with olaparib (per os) 150 mg twice a day versus trabectedin 1.5 mg/m2 intravenous 24-hour continuous infusion every 3 weeks until progression or unacceptable toxicity as second- or further-line treatment in a population of STS patients who have already received or are not suitable for a doxorubicin-based treatment.

Conditions

• Advanced Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Standard arm: Trabectedin in monotherapy	Trabectedin in monotherapy
DRUG	Experimental arm: Trabectedin + Olaparib	Trabectedin given in combination to olaparib

Timeline

• Start date: 2020-05-20
• Primary completion: 2024-11-29
• Completion: 2024-11-29
• First posted: 2019-02-12
• Last updated: 2024-12-04

Locations

13 sites across 1 country: Italy