Clinical trial · Interventional
Study Escalating Doses of PM01183 in Combination With Fixed Doxorubicin in Patients With Specific Advanced Unresectable Solid Tumors
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination With Doxorubicin in Non-heavily Pretreated Patients With Selected Advanced Solid Tumors
- 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)
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 in Combination with Fixed Doxorubicin in Non- Heavily Pretreated Patients with Selected Advanced Solid Tumors to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 in combination with doxorubicin, to characterize the safety profile and feasibility of this combination, to characterize the pharmacokinetics (PK) of this combination, to obtain preliminary information on the clinical antitumor activity,to explore the feasibility, safety and efficacy of a potential improvable dose of this combination in selected tumor types \[i.e. small cell lung cancer (SCLC) and endometrial cáncer\] and to evaluate the pharmacogenomics (PGx) in tumor samples of patients exposed to PM01183 and doxorubicin at the RD in order to assess potential markers of response and/or resistance.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Adenocarcinomas | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Small-cell Lung Cancer With Less Than 2 Prior Cytotoxic-containing Lines of Therapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| lurbinectedin (PM01183) | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lurbinectedin (PM01183) / doxorubicin
- interventionNames
- Drug: lurbinectedin (PM01183)
- Drug: Doxorubicin
Primary outcomes (3)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- During the first cycle of treatment, up to 28 days
- description
- A minimum of three patients will be included at each DL. If no patients experience a DLT during Cycle 1, the dose will be escalated. If one of three patients experiences a DLT, three additional patients will be included at that level. If \>1 evaluable patient during dose escalation at a given DL experience a DLT during Cycle 1, that DL will be considered the MTD and dose escalation will be terminated, except if all DLTs are related to neutropenia exclusively, in which case dose escalation may be resumed as originally planned in a new cohort of patients but with compulsory primary G-CSF prophylaxis.
- measure
- Recommended Dose (RD)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily written informed consent * Age: between 18 and 75 years (both inclusive). * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1. Cohort of patients with SCLC and endometrial cáncer ECOG PS ≤ 2. * Life expectancy ≥ 3 months. * Patients with a histologically/cytologically confirmed diagnosis of advanced disease of any of the following tumors: 1. Breast cancer 2. Soft-tissue sarcoma 3. Primary bone sarcomas. 4. Gynecologic tumors (endometrial adenocarcinomas, epithelial ovarian cancer...) 5. Hepatocellular carcinoma 6. Gastroenteropancreatic neuroendocrine tumors 7. Small cell lung cancer (SCLC) 8. Gastric cancer 9. Bladder cancer 10. Adenocarcinoma of unknown primary site * At least three weeks since the last anticancer therapy, including radiotherapy * Adequate bone marrow, renal, hepatic, and metabolic function * Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan within normal range (according to institutional standards). * Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six weeks after discontinuation of treatment Exclusion Criteria: * Concomitant diseases/conditions: * History or presence of unstable angina, myocardial infarction, congestive heart failure, or clinically significant valvular heart disease within last year. * Symptomatic or any uncontrolled arrhythmia * Ongoing chronic alcohol consumption, or cirrhosis * Active uncontrolled infection. * Known human immunodeficiency virus (HIV) infection. * Any other major illness that, in the Investigator's judgment * Brain metastases or leptomeningeal disease involvement. * Men or women of childbearing potential who are not using an effective method of contraception * Patients who have had radiation therapy in more than 35% of the bone marrow. This criterion will not apply to cohort of patients with SCLC and endometrial cáncer. * History of previous bone marrow and/or stem cell transplantation.
References
Publications (1)
- DERIVEDOlmedo ME, Forster M, Moreno V, Lopez-Criado MP, Brana I, Flynn M, Doger B, de Miguel M, Lopez-Vilarino JA, Nunez R, Kahatt C, Cullell-Young M, Zeaiter A, Calvo E. Efficacy and safety of lurbinectedin and doxorubicin in relapsed small cell lung cancer. Results from an expansion cohort of a phase I study. Invest New Drugs. 2021 Oct;39(5):1275-1283. doi: 10.1007/s10637-020-01025-x. Epub 2021 Mar 11. PMID 33704620