Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Inclusion Criteria

• •Age ≥ 18 years.
• •Voluntary signed informed consent (IC)
• •Pathologically proven diagnosis of any of the following malignancies:
• •* Small cell lung cancer (SCLC).
• •* Head and neck carcinoma (H\&N). Salivary glands tumors are excluded.
• •* Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
• •* Biliary tract carcinoma.
• •* Endometrial carcinoma.
• •* BRCA 1/2- associated metastatic breast carcinoma
• •* Carcinoma of unknown primary site.
• •* Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
• •* Ewing's family of tumors (EFTs)
• •Prior treatment. Patients must have received:
• •* SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
• •* H\&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
• •* GCTs: no limit of prior therapy
• •* EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
• •* BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
• •Performance status ≤ 2 \[Eastern Cooperative Oncology Group (ECOG)\]
• •Adequate major organ function
• •At least three weeks since the last chemotherapy
• •Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry