Clinical trial · Interventional
Study of PM060184 in Patients With Advanced Solid Tumors
Phase I, Multicenter, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM060184 Administered Intravenously to Patients With Advanced Solid Tumors
NCT01299636CI-TRIAL-00019666completedPhase 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)
The purpose of the study is to determine the maximum tolerated dose and the recommended dose and to evaluate the safety and tolerability of PM060184.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PM060184 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PM060184
- interventionNames
- Drug: PM060184
Primary outcomes (1)
- measure
- MTD (maximum tolerated dose) and RD (recommended dose) of PM060184.
- timeFrame
- From treatment onset to end of treatment
- description
- To determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM060184 administered on Days 1 and 8 of a 21-day cycle intravenously (i.v.) over 10 minutes to patients with advanced solid tumors.
Secondary outcomes (2)
- measure
- To determine the pharmacokinetics of this drug in patients who have advanced solid tumors.
- timeFrame
- Blood samples will be collected up to 48 hours after the first infusion. At the RD, 24-h urine collection samples and 15 additional blood samples up to 48 hours after the second infusion of the first cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria 1. Voluntary signed and dated written informed consent. 2. Patients with advanced solid tumors refractory to Standard therapy. 3. Age \>/= 18 years. 4. Recovery from drug-related adverse events (AEs) of previous treatments, excluding alopecia. 5. Normal laboratory values within seven days prior to treatment administration. 6. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both men and women must agree to use a medically acceptable method of contraception throughout the treatment period and for three months after discontinuation of treatment. Exclusion criteria 1. Pregnant or lactating women. 2. Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy 3. Prior treatment with any investigational product less than 30 days prior to the first. 4. Central Nervous System metastases 5. Other relevant diseases or adverse clinical conditions: * Increased cardiac risk: * Presence of significant neurological or psychiatric disorders * Neuropathy * Active infection requiring treatment. * Liver disease (e.g., cirrhosis, hepatitis). * Immunocompromised patients. * Any other major illness. 6. Limitation of the patient's ability to comply with the treatment. 7. Known hypersensitivity to any of the components of the drug product.
References
Publications (1)
- DERIVEDGhalib MH, Pulla MP, De Miguel Luken MJ, de Juan VC, Chaudhary I, Hammami MB, Vikash S, Maitra R, Martinez S, Kahatt C, Extremera S, Fudio S, Goel S. A phase I safety and efficacy clinical trial of plocabulin and gemcitabine in patients with advanced solid tumors. Invest New Drugs. 2024 Oct;42(5):481-491. doi: 10.1007/s10637-024-01458-8. Epub 2024 Aug 3. PMID 39096398