* ClinicalTrials Identifier: NCT02398058 .
* Updated: 2015_03_24 .
Descriptive Information :
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.
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.
Administrative Data :
Organization name Italian Sarcoma Group
Organization study ID TOMAS
Secondary ID 2013-003638-33 (EudraCT Number)
Sponsor Italian Sarcoma Group
Collaborator PharmaMar
Collaborator AstraZeneca
Collaborator Istituto Di Ricerche Farmacologiche Mario Negri
Health Authority Italy: The Italian Medicines Agency
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