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This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment. Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.
This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label treatment with Pralatrexate | Other | Pralatrexate will be administered based on Child-Pugh Classification of liver impairment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pralatrexate Injection | Drug | Pralatrexate will be administered based on Child-Pugh Classification of liver impairment |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic (PK) profile of pralatrexate. | Blood will be collected to evaluate the pharmacokinetic (PK) profile of pralatrexate (plasma concentration levels) when administered to patients with various degrees of hepatic impairment. | During week 1 of the first cycle of treatment (each cycle is 7 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of pralatrexate | The number and severity of treatment-related adverse events. This will be as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale, Version 5.0. | This will be evaluated during the study through 14(±3) days after the last dose in Cycle 1, or 35(±5) days after the final dose in any cycle or until all treatment-related AEs have resolved or returned to Baseline/Grade |
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Inclusion Criteria:
Absolute neutrophil count (ANC) ≥1000/μL Platelet count ≥100,000/μL Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥50 mL/min
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uma Srinivas Atmuri | Contact | 732-917-2420 | uatmuri@acrotechbiopharma.com | |
| Motun Clinical Trial Manager | Contact | 617-694-4296 | msolomon@acrotechbiopharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Erard Gilles, MD, MSc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOI Clinical Research | Withdrawn | Cerritos | California | 90703 | United States | |
| Northwestern University - Feinberg School of Medicine |
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| Recruiting |
| Chicago |
| Illinois |
| 60611 |
| United States |
|
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
|
| Gabrail Cancer Center | Recruiting | Canton | Ohio | 44718 | United States |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C418863 | 10-propargyl-10-deazaaminopterin |
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