Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

Main Inclusion Criteria:

• Written informed consent
• Progressive locally advanced or metastatic malignancy
• Prior administration of standard treatment for primary and relapsed malignancy
• Eastern Cooperative Oncology Group Performance Status ≤1
• Patients with central venous access device in place (central venous catheter or porta-cath)
• Age ≥18 and ≤70 years
• Identification of defective DNA repair via HR
• Adequate bone marrow, renal, and hepatic function
• Hemoglobin ≥10 g/dl
• Neutrophil count ≥1,500/mm3
• Platelet count ≥100,000/µl
• Bilirubin ≤1.5 x upper limit of normal (ULN)
• ALT and AST ≤2.5 x ULN (≤5 x ULN in patients with hepatic tumor involvement)
• Alkaline phosphatase ≤2.5 x ULN
• PT-INR/PTT ≤1.5 x ULN
• Albumin ≥25 g/l
• Creatine kinase ≤2.5 x ULN
• Serum creatinine 1.5 mg/dl or creatinine clearance 51 ml/min

Main Exclusion Criteria:

• Hematological malignancies and primary brain tumors.
• Concurrent treatment in another interventional clinical trial
• Prior treatment with PARP Inhibitors
• Patients with platinum-refractory disease, defined as progressive disease during or immediately after treatment with platinum based chemotherapy
• Persistent toxicity (> Grade 2 according to CTCAE 5.0)
• Dementia or significant impairment of cognitive state
• History of HIV infection
• Clinical signs of active infection (>Grade 2 according to CTCAE 4.03)
• History of viral hepatitis (HBV or HCV)
• Epilepsy requiring pharmacologic treatment
• Pregnancy
• Major surgical intervention 4 weeks prior to study inclusion
• Known hypersensitivity to any of the study drugs
• Hematologic malignancy
• QTc time prolongation >500 ms or history of familial long-QT-syndrome
• Heart failure NYHA III/IV
• Severe obstructive or restrictive ventilation disorder
• Concomitant use of known strong CYP3A Inhibitors
• Concomitant use of known strong CYP3A inducers