Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Olaparib

Trabectedin

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

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)

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

Standard arm: Trabectedin in monotherapy

Trabectedin given in combination to olaparib

Experimental arm: Trabectedin + Olaparib

Giovanni Giovanni, MD

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.

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.

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.

Survival from the first dose treatment to death for any cause

Proportion of patients who are still alive at 12 months after have started the treatment

Proportion of patients who did not progress at 6 months after have started the treatment

Ratio of time to progression with the nth line of therapy to the those with the n-1th line.

Safety in term of adverse event is evaluate from the firs treatment dose throughout the study according to CTCAE 5.0

Evaluation of the quality of life collected with EORTC Quality of Life Questionnaire C30

Evaluation of the quality of life collected with EQ-5D

Overall response rate according Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.	NCT03838744	Advanced Soft T...	Standard arm: T... Experimental ar...	18 Years -	Italian Sarcoma Group
Randomized Trial in Advanced, Metastatic or Unresectable Soft Tissue Sarcoma After Failure of Standard Treatments.	NCT03838744	Advanced Soft T...	Standard arm: T... Experimental ar...	18 Years -	Italian Sarcoma Group

Spots Global Cancer Trial Database for standard arm: trabectedin in monotherapy