Pralatrexate for Cancer

(SPI-FOL-102 Trial)

Recruiting at 1 trial location

Overseen By Motun Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Acrotech Biopharma Inc.

Must not be taking: Investigational drugs

Disqualifiers: Pralatrexate exposure, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

24 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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

I agree to use two forms of birth control, including a barrier method, until 30 days after my last dose.

I am willing and able to follow the study's requirements and visit schedules.

My blood and kidney tests meet the required levels.

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I have not had major surgery in the last 30 days.

I have been treated with pralatrexate before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pralatrexate is administered once weekly for 6 weeks in a 7-week treatment cycle

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pralatrexate

Trial Overview

The trial tests Pralatrexate Injection's pharmacokinetics—how it's absorbed, metabolized, and excreted in cancer patients with varying liver health. It involves weekly doses over a 7-week cycle to determine safe dosing guidelines.

How Is the Trial Designed?

Group I: Open-label treatment with Pralatrexate Experimental Treatment 1 Intervention

Pralatrexate will be administered based on Child-Pugh Classification of liver impairment.

Who Is Running the Clinical Trial?

Acrotech Biopharma Inc.

Lead Sponsor

Trials

31

Recruited

5,200+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40526835/

Pralatrexate is effective in cytotoxic cutaneous T-cell ...

The overall response rate was 100%, with 12 (67%) achieving complete response (CR). Median duration of progression-free survival and overall ...

2.

ashpublications.org

ashpublications.org/bloodadvances/article/9/15/4037/537799/Pralatrexate-is-effective-in-cytotoxic-cutaneous-T

Pralatrexate is effective in cytotoxic cutaneous T-cell lymphomas

Pralatrexate exhibited high efficacy in cytotoxic CTCL, with an overall response rate of 100% and a CR rate of 67%.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2473952925003374

Pralatrexate is effective in cytotoxic cutaneous T-cell ...

Pralatrexate exhibited high efficacy in cytotoxic CTCL, with an overall response rate of 100% and a CR rate of 67%. •. Pralatrexate showed ...

4.

bloodcancerstoday.com

bloodcancerstoday.com/post/pooled-data-analysis-offers-clues-on-increased-efficacy-with-pralatrexate-for-ptcl

Pooled Data Analysis Offers Clues on Increased Efficacy ...

The combined cohort received pralatrexate for a median of 2.56 months. These patients had an objective response rate of 40.7%, with a median ...

5.

nature.com

nature.com/articles/s41598-019-56891-0

Pralatrexate in patients with recurrent or refractory ...

Our study showed relatively lower ORR and shorter PFS in patients with recurrent or refractory PTCLs treated with pralatrexate in real-world practice.

6.

aetna.com

aetna.com/cpb/medical/data/700_799/0740.html

Pralatrexate - Medical Clinical Policy Bulletins

This pralatrexate therapy showed good safety profile that with little to no additional influence on the hepatic, renal function as well as body weight changes ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3627334/

Safety and efficacy of pralatrexate in the treatment of patients ...

Treatment with pralatrexate resulted in a significant reduction in tumor burden after two doses. These data supported further investigation of pralatrexate in ...

8.

oncologynewscentral.com

oncologynewscentral.com/drugs/monograph/153046-310001/pralatrexate-intravenous

Pralatrexate: uses, dosing, warnings, adverse events, ...

Safety and efficacy of pralatrexate have not been established in pediatric patients. ... Although no overall differences in safety and efficacy were observed in ...

9.

mayoclinic.org

mayoclinic.org/drugs-supplements/pralatrexate-intravenous-route/description/drg-20073415

Pralatrexate (intravenous route) - Side effects & uses

Pralatrexate belongs to the group of medicines called antineoplastics (cancer medicines). ... Safety and efficacy have not been established.

10.

cancercareontario.ca

cancercareontario.ca/en/drugformulary/drugs/monograph/59781

PRALAtrexate

Severe and potentially life-threatening dermatologic reactions, including skin exfoliation, ulceration, and toxic epidermal necrolysis (TEN), have been reported ...