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

Pharma Mar

Status and phase: Completed; Phase 2

Conditions: Advanced Solid Tumors

Treatments: Drug: lurbinectedin (PM01183)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02454972

PM1183-B-005-14

Details and patient eligibility

About

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

Full description

Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).

Enrollment: 345 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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345 participants in 1 patient group

lurbinectedin (PM01183)

Experimental group

Description:

lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion

Treatment:

Drug: lurbinectedin (PM01183)