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PAS-004 for Neurofibromatosis

Phase 1

Recruiting

Research Sponsored by Pasithea Therapeutics Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1: day 1 and day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), day 4, 8, 15, 29 and 35 (predose)

Awards & highlights

Study Summary

This trial aims to test a drug called PAS-004 in people with advanced solid tumors that have specific mutations. It will evaluate how well participants tolerate different doses of PAS-004 and what side effects the

Who is the study for?

This trial is for adults with advanced solid tumors that have specific genetic changes (RAS, NF1, or RAF mutations). Participants should be able to swallow pills and attend regular study visits. They must not have other medical conditions that could interfere with the study or be taking certain medications.Check my eligibility

What is being tested?

PAS-004 is being tested in this trial. It's a medication taken by mouth as a single dose initially, then daily in 28-day cycles for up to two years unless side effects become too severe or the disease gets worse. The goal is to find out how much of PAS-004 can be safely taken and what its potential side effects are.See study design

What are the potential side effects?

Possible side effects of PAS-004 may include typical drug reactions like nausea, fatigue, allergic responses, and possibly unique risks due to its action on RAS/RAF pathways which will be monitored closely during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1: day 1 and day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), day 4, 8, 15, 29 and 35 (predose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1: day 1 and day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), day 4, 8, 15, 29 and 35 (predose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1: day 1 and day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), day 4, 8, 15, 29 and 35 (predose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004.

Evaluation of adverse events (AEs)

Evaluation of clinical chemistry laboratory parameters

+2 more

Secondary outcome measures

Apparent terminal elimination half-life (t1/2) in Plasma

Apparent total plasma clearance if possible (CL/F)

Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PAS-004Experimental Treatment1 Intervention

Sequential dose escalation: 2 mg, 4 mg, 6 mg, 9 mg, 12 mg, 15 mg, and 18 mg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pasithea Therapeutics Corp.Lead Sponsor

Graeme Currie, PhDStudy DirectorPasithea Therapeutics Corp.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different sites is the administration of this trial being managed?

"The current recruitment phase of this study includes 4 active sites in Austin, Irving, Fairfax, and additional undisclosed locations. Opting for the nearest site is crucial to reduce travel commitments for potential participants."

Answered by AI

Are individuals currently able to participate in this ongoing medical study?

"As per clinicaltrials.gov, this specific trial is currently in the recruitment phase. The initial posting was on February 29th, 2024, with the most recent update noted on March 1st of the same year."

Answered by AI

What is the total number of individuals currently under research in this clinical trial?

"Affirmative, the information available on clinicaltrials.gov affirms that this investigation is actively seeking volunteers. This study was initially disclosed on February 29th, 2024 and underwent its most recent revision on March 1st of the same year. The research aims to recruit a total of 42 subjects distributed among four distinct sites."

Answered by AI

Has the medication PAS-004 received approval from the FDA?

"As a Phase 1 trial, the safety rating for PAS-004 is rated as 1 according to our team at Power. This indicates that there exists minimal data supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PAS-004 in Patients With Advanced Solid Tumors

2024. "PAS-004 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06299839.

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