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Brief Title: Trabectedin Plus Olaparib in Metastatic or Advanced Sarcomas (TOMAS)
Official Title: A Phase Ib Study on the Combination of Trabectedin and Olaparib in Unresectable Advanced/Metastatic Sarcomas After Failure of Standard Therapies
Study ID: NCT02398058
Brief Summary: This is a Phase 1b, multi-site, open-label, non-randomized clinical trial evaluating the safety, tolerability, and pharmacokinetics of escalating doses of olaparib and trabectedin in patients with unresectable advanced/metastatic sarcomas. Patients will continue to be treated on this combination regimen in the absence of disease progression, intolerable toxicity or patient's decision.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo, Torino, Italy
Istituti Ortopedici Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors, Bologna, , Italy
Istituto Nazionale Tumori - Unit of Medical Oncology, Milano, , Italy
Name: Giovanni Grignani, MD
Affiliation: Italian Sarcoma Group
Role: PRINCIPAL_INVESTIGATOR