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

Recruiting Phase 1 Interventional Study
Advanced Solid Tumors Hematologic Malignancies
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Acrotech Biopharma Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements * Patient is diagnosed with advanced solid tumor or hematological malignancy. * Patient is at least 18 years o…
Contacts

Uma Srinivas Atmuri

732-917-2420

uatmuri@acrotechbiopharma.com

CONTACT

Motun Clinical Trial Manager

617-694-4296

msolomon@acrotechbiopharma.com

CONTACT