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

• Status: Active, not recruiting
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PharmaMar

Criteria

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