{"groups":[{"description":"Patients with Pathologically proven diagnosis of biliary tract carcinoma\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG000","title":"Biliary Tract Carcinoma Cohort"},{"description":"Patients with pathologically proven diagnosis of carcinoma of unknown primary site\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG001","title":"Carcinoma of Unknown Primary Site Cohort"},{"description":"Patients with pathologically proven diagnosis of endometrial carcinoma\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG002","title":"Endometrial Carcinoma Cohort"},{"description":"Patients with pathologically proven diagnosis of Ewing's Family of Tumors\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG003","title":"Ewing's Family of Tumors Cohort"},{"description":"Patients with pathologically proven diagnosis of Germ Cell Tumors, excluding immature teratoma, or teratoma with malignant transformation.\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG004","title":"Germ Cell Tumors Cohort"},{"description":"Patients with Pathologically proven diagnosis of Head and Neck Carcinoma. Salivary glands tumors were excluded.\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG005","title":"Head and Neck Carcinoma Cohort"},{"description":"Patients with pathologically proven diagnosis of BRCA1/2-associated metastatic breast carcinoma\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG006","title":"BRCA1/2-associated Metastatic Breast Carcinoma Cohort"},{"description":"Patients with Pathologically proven diagnosis of Neuroendocrine Tumors, grade 2 and 3 according to World Health Organization (WHO) classification.\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG007","title":"Neuroendocrine Tumors Cohort"},{"description":"Patients with pathologically proven diagnosis of small cell lung cancer\n\nLurbinectedin was administered over a minimum total volume of 100 mL of solution for infusion (either on 5% glucose or 0.9% sodium chloride), through a central catheter, or over a minimum total volume of 250 mL if administered through a peripheral line, always over one hour at a fixed infusion rate. Starting dose was 3.2 mg/m\\^2. Dose was capped at body surface area (BSA) of 2.0 m\\^2 (i.e., dose did not exceed 6.4 mg).\n\nPatients received lurbinectedin intravenously (i.v.) as a one-hour infusion on Day 1 q3wk (three weeks = one treatment cycle).","id":"FG008","title":"Small Cell Lung Cancer Cohort"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"59"},{"groupId":"FG003","numSubjects":"23"},{"groupId":"FG004","numSubjects":"16"},{"groupId":"FG005","numSubjects":"12"},{"groupId":"FG006","numSubjects":"19"},{"groupId":"FG007","numSubjects":"27"},{"groupId":"FG008","numSubjects":"0"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"95"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"1"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"0"}],"type":"Non treatment-related adverse event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"2"},{"groupId":"FG008","numSubjects":"0"}],"type":"Treatment-related adverse events"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"2"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Patient moves to compassionate use"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"3"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"1"},{"groupId":"FG008","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"Multiple delay/holds on treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"5"}],"type":"Never treated"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"6"}],"type":"Study termination"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"76"},{"groupId":"FG003","numSubjects":"29"},{"groupId":"FG004","numSubjects":"24"},{"groupId":"FG005","numSubjects":"15"},{"groupId":"FG006","numSubjects":"21"},{"groupId":"FG007","numSubjects":"32"},{"groupId":"FG008","numSubjects":"110"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"73"},{"groupId":"FG003","numSubjects":"28"},{"groupId":"FG004","numSubjects":"23"},{"groupId":"FG005","numSubjects":"15"},{"groupId":"FG006","numSubjects":"21"},{"groupId":"FG007","numSubjects":"32"},{"groupId":"FG008","numSubjects":"105"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"19"},{"groupId":"FG002","numSubjects":"76"},{"groupId":"FG003","numSubjects":"29"},{"groupId":"FG004","numSubjects":"24"},{"groupId":"FG005","numSubjects":"15"},{"groupId":"FG006","numSubjects":"21"},{"groupId":"FG007","numSubjects":"32"},{"groupId":"FG008","numSubjects":"110"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The first patient registration was on 25 August 2015 and the first study treatment administration was on 25 August 2015. The last patient registration was on 30 November 2018 and the last study treatment administration was on 29 November 2019. The date of last follow-up (cutoff-date) was 18 September 2020."}