Clinical trial · Interventional
Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
NCT02454972CI-TRIAL-00064384completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lurbinectedin (PM01183) | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lurbinectedin (PM01183)
- description
- lurbinectedin (PM01183) 4 mg vials of powder for concentrate for solution for infusion
- interventionNames
- Drug: lurbinectedin (PM01183)
Primary outcomes (2)
- measure
- Overall Response Rate (ORR)
- timeFrame
- From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)
- description
- Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- DERIVEDKristeleit 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. PMID 37556023
- DERIVEDBoni 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. PMID 36037567
- DERIVEDLongo-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. PMID 35830841
- DERIVEDSubbiah 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. PMID 35486638
- DERIVEDFernandez-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. PMID 34739582