Spots Global Cancer Trial Database for Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors
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Trial Identification
Brief Title: Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors
Official Title: A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies
Study ID: NCT03127215
Conditions
Study Description
Brief Summary: Evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients with locally advanced/metastatic solid tumors that failed standard treatment and whose molecular sequencing tumor profiles show homologous recombination repair (HRR) defects. The primary objective is to show superior disease control rate in patients with HRR-deficient tumors treated with olaparib and trabectedin compared to treatment according to current guidelines (physician's choice). This trial aims to establish whether the PARP-dependency of HRR-deficient tumors across entities can be exploited for therapeutic benefit.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Fakultät der TU Dresden, Dresden, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
National Center for Tumordiseases (NCT), Heidelberg, , Germany
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Mainz, , Germany
Klinikum der Universität München-Großhadern, München, , Germany
Klinik Schillerhöhe, Stuttgart, , Germany
Universitätsklinikum Tübingen, Tuebingen, , Germany
Contact Details
Name: Stefan Froehling, MD
Affiliation: NCT / DKFZ Heidelberg
Role: PRINCIPAL_INVESTIGATOR
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