Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
NCT ID: NCT02454972
Last Updated: 2023-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
345 participants
INTERVENTIONAL
2015-08-25
2020-09-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lurbinectedin (PM01183)
lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
lurbinectedin (PM01183)
Interventions
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lurbinectedin (PM01183)
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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PharmaMar
INDUSTRY
Responsible Party
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Locations
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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
Complexo Hospitalario Universitario A Coruña
A Coruña, , Spain
Hospital Universitari Vall D' Hebron
Barcelona, , Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Madrid Sanchinarro
Madrid, , Spain
Complejo Hospitalario de Especialidades Virgen de la Victoria
Málaga, , Spain
Hospital Universitari i Polotècnic la Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Skane University Hospital
Lund, , Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
Istituto Oncologico della Svizzera Italiana (IOSI)
Bellinzona, , Switzerland
UCL Cancer Institute
London, , United Kingdom
Countries
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References
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Kristeleit R, Leary A, Delord JP, Moreno V, Oaknin A, Castellano D, Shappiro GI, Fernandez C, Kahatt C, Alfaro V, Siguero M, Rueda D, Zeaiter A, Awada A, Santaballa A, Zaman K, Sehouli J, Subbiah V. Lurbinectedin in patients with pretreated endometrial cancer: results from a phase 2 basket clinical trial and exploratory translational study. Invest New Drugs. 2023 Oct;41(5):677-687. doi: 10.1007/s10637-023-01383-2. Epub 2023 Aug 9.
Boni V, Pistilli B, Brana I, Shapiro GI, Trigo J, Moreno V, Castellano D, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Longo F, Zaman K, Anton A, Paredes A, Huidobro G, Subbiah V. Lurbinectedin, a selective inhibitor of oncogenic transcription, in patients with pretreated germline BRCA1/2 metastatic breast cancer: results from a phase II basket study. ESMO Open. 2022 Oct;7(5):100571. doi: 10.1016/j.esmoop.2022.100571. Epub 2022 Aug 28.
Longo-Munoz F, Castellano D, Alexandre J, Chawla SP, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-Garcia E, Awada A, Santaballa A, Subbiah V. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340-348. doi: 10.1016/j.ejca.2022.06.024. Epub 2022 Jul 10.
Subbiah V, Brana I, Longhi A, Boni V, Delord JP, Awada A, Boudou-Rouquette P, Sarantopoulos J, Shapiro GI, Elias A, Ratan R, Fernandez C, Kahatt C, Cullell-Young M, Siguero M, Zeaiter A, Chawla SP. Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study. Clin Cancer Res. 2022 Jul 1;28(13):2762-2770. doi: 10.1158/1078-0432.CCR-22-0696.
Fernandez-Teruel C, Fudio S, Lubomirov R. Integrated exposure-response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer. Cancer Chemother Pharmacol. 2022 May;89(5):585-594. doi: 10.1007/s00280-021-04366-3. Epub 2021 Nov 5.
Subbiah V, Paz-Ares L, Besse B, Moreno V, Peters S, Sala MA, Lopez-Vilarino JA, Fernandez C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Zaman K, Lopez R, Ponce S, Boni V, Arrondeau J, Delord JP, Martinez M, Wannesson L, Anton A, Valdivia J, Awada A, Kristeleit R, Olmedo ME, Rubio MJ, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D' Arcangelo M, Santoro A, Villalobos VM, Sands J, Trigo J. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment. Lung Cancer. 2020 Dec;150:90-96. doi: 10.1016/j.lungcan.2020.10.003. Epub 2020 Oct 10.
Trigo J, Subbiah V, Besse B, Moreno V, Lopez R, Sala MA, Peters S, Ponce S, Fernandez C, Alfaro V, Gomez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martinez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PM1183-B-005-14
Identifier Type: -
Identifier Source: org_study_id
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