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

Who is this study for? Adult patients with Resectable or Metastatic Soft Tissue Sarcoma
What treatments are being studied? Trabectedin
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Provision of written informed consent prior to any study specific procedures.

• Patients with histologically documented and not surgically resectable or metastatic STS that progressed after first- or further-line treatments for relapsing disease.

• At least one previous line of anthracycline-containing chemotherapy for advanced disease or relapsed/progressed within six months of a previous treatment with an anthracycline-containing chemotherapy in the neo-adjuvant/adjuvant setting.

• Central revision will be mandatory in order to enroll a patient. Central revision will assess both diagnosis and adequacy of tumor specimen (minimum requisite will be a formalin-fixed paraffin-embedded block of either a 16-gauge tru-cut biopsy or a non-necrotic surgical tumor specimen). The patient has to consent BReast CAncer genes 1 and 2 (BRCA1 and BRCA 2) evaluation in the interest of avoiding misleading interpretation of resulting data.

• Measurable disease according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Patients with an ECOG 2 are eligible if it depends solely on orthopedic problems.

• Estimated life expectancy of at least 16 weeks.

• Age ≥18 years.

• Left Ventricular Ejection Fraction ≥ 50% and/or above lower institutional limit of normality

• Adequate bone marrow, liver and renal function assessed within 7 days prior to

• Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1

Locations
Other Locations
Italy
Centro di Riferimento Oncologico di Aviano
Recruiting
Aviano
Azienda Ospedaliero-Universitaria Di Bologna
Active, not recruiting
Bologna
Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors
Recruiting
Bologna
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Recruiting
Candiolo
I.R.S.T. di Meldola
Recruiting
Meldola
Fondazione IRCCS Istituto Nazionale dei Tumori
Recruiting
Milano
Istituto Europeo di Oncologia
Recruiting
Milano
Irccs Istituto Oncologico Veneto (Iov)
Recruiting
Padova
Azienda Ospedaliera Universitaria Paolo Giaccone
Not yet recruiting
Palermo
Nuovo Ospedale di Prato
Not yet recruiting
Prato
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I
Recruiting
Roma
Policlinico Universitario Campus Biomedico
Recruiting
Roma
Istituto Clinico Humanitas
Not yet recruiting
Rozzano
Ospedale San Giovanni Bosco
Not yet recruiting
Torino
Contact Information
Primary
Giovanni Giovanni, MD
giovanni.grignani@irccs.it
0039-011-993
Time Frame
Start Date: May 26, 2020
Estimated Completion Date: February 2025
Participants
Target number of participants: 126
Treatments
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
Sponsors
Collaborators: PharmaMar, AstraZeneca
Leads: Italian Sarcoma Group

This content was sourced from clinicaltrials.gov

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