Clinical Trials /

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

NCT02454972

Description:

A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors: 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)

Related Conditions:
  • Bile Duct Carcinoma
  • Breast Carcinoma
  • Carcinoma of Unknown Primary Origin
  • Endometrial Carcinoma
  • Ewing Sarcoma
  • Germ Cell Tumor
  • Head and Neck Carcinoma
  • Neuroendocrine Carcinoma
  • Neuroendocrine Tumor
  • Peripheral Primitive Neuroectodermal Tumor
  • Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
  • Official Title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: PM1183-B-005-14
  • NCT ID: NCT02454972

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
lurbinectedin (PM01183)lurbinectedin (PM01183)

Purpose

A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors to assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), in the following advanced solid tumors: 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)

Trial Arms

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

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks)
Safety Issue:
Description:Overall response rate (ORR), defined as the percentage of evaluable patients with a confirmed response, either complete (CR) or partial (PR).

Secondary Outcome Measures

Measure:Duration of response (DR)
Time Frame:Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks)
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks)
Safety Issue:
Description:
Measure:1 year overall survival (1y-OS) in each cohort of advanced solid tumors [overall survival (OS) instead of 1y-OS in the cohort of SCLC patients].
Time Frame:Every two cycles until Cycle 6 or evidence of progression disease (1 cycle duration: 3 weeks)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:PharmaMar

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