Pralatrexate for Cancer
(SPI-FOL-102 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called pralatrexate to understand its behavior in the body and determine the best dose for individuals with liver problems. It targets patients with advanced cancer, whether solid tumors or blood-related (hematological) cancers. Suitable candidates are those managing advanced cancer and experiencing liver issues. Researchers aim to ensure the drug's safety and assess its effects when the liver functions abnormally. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot use any investigational drugs, biologics, or devices within 30 days before the study or during the study.
Is there any evidence suggesting that pralatrexate is likely to be safe for humans?
Research has shown that pralatrexate is generally safe, typically not causing major issues with the liver, kidneys, or body weight. However, some risks exist. Certain patients have experienced serious skin reactions, which can be severe and even life-threatening. These reactions may include skin peeling, sores, or other serious skin conditions. While serious, they do not occur in everyone. The safety and effectiveness of pralatrexate remain under study, highlighting the importance of ongoing research.12345
Why do researchers think this study treatment might be promising?
Pralatrexate is unique because it specifically targets the folate pathway in cancer cells, which is different from many standard treatments like methotrexate or pemetrexed that target rapidly dividing cells more broadly. This focused approach allows pralatrexate to potentially deliver more effective results with possibly fewer side effects, as it hones in on cancerous cells with greater precision. Researchers are excited about pralatrexate because its mechanism of action promises improved outcomes for patients, especially those with liver impairment, by tailoring the treatment based on liver function using the Child-Pugh Classification.
What evidence suggests that pralatrexate might be an effective treatment for cancer?
Research has shown that pralatrexate, administered to participants in this trial, effectively treats certain skin cancers known as cutaneous T-cell lymphomas. In studies, all patients responded to the treatment, with 67% experiencing complete cancer remission. Another study found that 40.7% of patients with peripheral T-cell lymphomas responded to the treatment, though results varied. While strong evidence supports its effectiveness in some cancers, outcomes can differ depending on the cancer type. Overall, pralatrexate appears promising, especially for specific types of lymphoma.678910
Who Is on the Research Team?
Erard Gilles, MD, MSc
Principal Investigator
Are You a Good Fit for This Trial?
This trial is for patients with advanced solid tumors or blood cancers who have different levels of liver function, from normal to severe impairment. The study aims to understand how their bodies handle the drug Pralatrexate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Pralatrexate is administered once weekly for 6 weeks in a 7-week treatment cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pralatrexate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acrotech Biopharma Inc.
Lead Sponsor