Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This trial intends to determine the maximum tolerated dose and the recommended dose, to evaluate the safety and tolerability, to determine the pharmacokinetics and to evaluate the antitumor activity of PM060184 in patients with advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PM060184 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PM060184 | Drug | PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD (maximum tolerated dose) and RD (recommended dose) of PM060184. | 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. | From treatment onset to end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetics of this drug in patients who have advanced solid tumors. | The complete plasma concentration-time profiles of PM06184 will be analyzed by standard non-compartmental methods.The percent of PM060184 total dose excreted unchanged into the urine over the collection interval will be calculated from the urine samples. | 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. |
Not provided
Inclusion criteria
Exclusion criteria
Pregnant or lactating women.
Less than three weeks from radiation therapy or last dose of hormonal therapy, biological therapy or chemotherapy
Prior treatment with any investigational product less than 30 days prior to the first.
Central Nervous System metastases
Other relevant diseases or adverse clinical conditions:
Limitation of the patient's ability to comply with the treatment.
Known hypersensitivity to any of the components of the drug product.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kyriakos Papadopoulos, MD | START- South Texas Accelerated Research Therapeutics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START- South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39096398 | Derived | Ghalib 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C586200 | plocabulin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Antitumor activity | Antitumor activity will be measured according to the RECIST (Response Evaluation Criteria In Solid Tumors) version 1.1 or by evaluation of tumor markers | Every six weeks while on treatment. Patients who discontinued treatment without disease progression will be followed every three months until disease progression, other antitumor therapy, death or until the end-of-study date, whichever occurs first. |