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

Exclusion Criteria

• Prior treatment with PM01183 or trabectedin
• Prior or concurrent malignant disease unless in complete remission for more than five years
• Known central nervous system (CNS) involvement
• Relevant diseases or clinical situations which may increase the patient's risk
• Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception