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

Completed · Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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

Key facts

Study ID

NCT02454972

Run by

PharmaMar

People needed

345

Starts

2015-08-25

Expected to finish

2020-09-18

Last updated by the study team

2023-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sarcoma Oncology Research Center, LLC — Santa Monica, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Massachussets General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Centre — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Institute for Drug Development, Cancer Therapy & Research Center at University of Texas Health Science Center — San Antonio, Texas, United States
• Institut Jules Bordet — Brussels, Belgium
• Hôpital Cochin — Paris, France
• Institut Claudius Regaud — Toulouse, France
• Institut Gustave Roussy — Villejuif, France
• Charité Universitätsmedizin Berlin - Campus Benjamin Franklin - Comprehensive Cancer Center — Berlin, Germany
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Istituto Clinico Humanitas — Rozzano, Milan, Italy
• Istituto Ortopedico Rizzoli — Bologna, Italy
• lstituto Europeo di Oncologia — Milan, Italy
• ASST Monza - Ospedale San Gerardo di Monza Struttura Complessa di Oncologia Medica — Monza, Italy
• AUSL Romagna - Ospedale Santa Maria delle Croci — Ravenna, Italy
• Complexo Hospitalario Universitario de Santiago — Santiago de Compostela, A Coruña, Spain
• Hopsital Universitario Donostia - Donostia Unibertsitate Ospitalea — San Sebastián, Guipúzcoa, Spain
• Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Madrid, Spain
• Complejo Hospitalario De Navarra — Pamplona, Navarre, Spain
• Hospital Universitario Álvaro Cunqueiro — Vigo, Pontevedra, Spain
• Hospital Universitario Central de Asturias — Oviedo, Principality of Asturias, Spain
• Hospital de Basurto — Bilbao, Vizcaya, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.