Clinical trial · Interventional
Study of PM01183 in Non-Colorectal Cancer Patients as a Days 1 and 8 Intravenous Short Infusion Every 3 Weeks
Phase I Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM01183 on Days 1 and 8 Every Three Weeks (q3wk) in Non-Colorectal Cancer (Non-CRC) Patients
NCT01405391CI-TRIAL-00020550completedPhase 1ClinicalTrials.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)
Phase I Study of PM01183 in Non-Colorectal Cancer Patients to determine the recommended dose (RD) of PM01183.
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 |
|---|---|---|---|
| Major Advanced Solid Tumors Other Than Colorectal | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PM01183 | Drug | Lurbinectedin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- Patients will receive PM01183 on Days 1 and 8 q3wk (three weeks = one treatment cycle) as an i.v. infusion, starting at 3.0 mg/day, flat dose (FD), over a minimum total volume of 100 ml dilution (on 5% glucose or 0.9% sodium chloride) via a central catheter or over a minimum total volume of 250 ml via a peripheral line, over one hour (at a fixed rate) and through a pump device.
- interventionNames
- Drug: PM01183
Primary outcomes (1)
- measure
- Recommended dose (RD)
- timeFrame
- From treatment onset to end of treatment
- description
- To determine the recommended dose (RD) of PM01183 administered as a 1-hour infusion intravenously (i.v.) on Days 1 and 8 every three weeks (q3wk) in non-colorectal cancer (non-CRC) patients.
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily signed and dated written informed consent 2. Age ≥ 18 years. 3. Non or minimally daily activities-interfering disease related symptoms. 4. Life expectancy ≥ 3 months. 5. Patients with solid tumor other than CRC. 6. Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ≤ 7 days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed). 7. Normal cardiac function cardiac function by appropriate image testing. 8. Women of childbearing potential must have a negative serum pregnancy test before study entry. Exclusion Criteria: 1. Primary colorectal cancer diagnosis 2. Prior treatment with PM01183. 3. Concomitant diseases/conditions: a) History of a clinically relevant cardiac condition c) Known chronic liver disease. d) Active uncontrolled infection. e) Known human immunodeficiency virus (HIV) infection. f) Limitation of the patient's ability to comply with the treatment or follow-up protocol. 4. Symptomatic and progressive or corticosteroid-requiring documented brain metastases 5. Men or women of childbearing potential who are not using an effective method of contraception as previously described; women who are pregnant or breast feeding. 6. History of extensive prior pelvic irradiation. 7. History of previous bone marrow and/or stem cell transplantation.
References
Publications (1)
- DERIVEDFernandez-Teruel C, Lubomirov R, Fudio S. Population Pharmacokinetic-Pharmacodynamic Modeling and Covariate Analyses of Neutropenia and Thrombocytopenia in Patients With Solid Tumors Treated With Lurbinectedin. J Clin Pharmacol. 2021 Sep;61(9):1206-1219. doi: 10.1002/jcph.1886. Epub 2021 Jun 9. PMID 33914350