Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment

Part of paid clinical trials in Cerritos, California.

Sponsor
Acrotech Biopharma Inc.
Study ID
NCT07036133
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pralatrexate Injection — DRUG
    Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

Study Details

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.

Key Dates

Start date
Dec 28, 2022
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Open-label treatment with Pralatrexate
    Pralatrexate will be administered based on Child-Pugh Classification of liver impairment.

Primary Outcome Measure

To evaluate the pharmacokinetic (PK) profile of pralatrexate. [ Time Frame: During week 1 of the first cycle of treatment (each cycle is 7 weeks). ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
TOI Clinical ResearchCerritosCalifornia90703-
Northwestern University - Feinberg School of MedicineChicagoIllinois60611
Devalingam Mahalingam, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Wasif Saif, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer CenterCantonOhio44718
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cerritos, CA

By research site
TOI Clinical Research· Cerritos, CANorthwestern University - Feinberg School of Medicine· Chicago, ILKarmanos Cancer Institute· Detroit, MIGabrail Cancer Center· Canton, OH

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