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

Sponsor
Italian Sarcoma Group
Study ID
NCT03838744
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 20, 2020
Status verified
Nov 2024
Primary completion
Nov 29, 2024
Completion
Nov 29, 2024

Study Design

Enrollment
130 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard arm: Trabectedin in monotherapy
    Trabectedin in monotherapy at the dose 1.5 or 1.3 mg/m2 (according institutional practice) given as intravenous infusion at day 1 every 3 weeks (21 days cycle)
  • Experimental: Experimental arm: Trabectedin + Olaparib
    Trabectedin at the dose 1.1mg/m2 given as intravenous infusion at day 1 every 3 weeks (21 days cycle) plus Olaparib per os at the dose of 150 mg twice a day

Primary Outcome Measure

Progression free Survival (PFS) [ Time Frame: At 6 months ]

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