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fb-PMT for Glioblastoma
Phase 1
Recruiting
Led By Nicholas Blondin, MD
Research Sponsored by NanoPharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically proven intracranial glioblastoma, with first or second recurrence
Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
Study Summary
This trial is studying a new cancer drug to see if it is effective in treating brain tumors.
Who is the study for?
This trial is for adults with recurrent glioblastoma, a type of brain tumor. Participants must have had prior treatment, be on stable steroids if used, and have good performance status. They should not be pregnant or breastfeeding, have serious heart conditions or bleeding disorders, nor can they take certain medications that affect the heart rhythm.Check my eligibility
What is being tested?
The study tests fb-PMT's safety and tolerability to determine the appropriate dose for treating recurrent glioblastoma. It involves daily subcutaneous injections by patients or caregivers who must also maintain a treatment diary.See study design
What are the potential side effects?
Potential side effects of fb-PMT are not detailed in this summary but may include typical drug-related reactions such as injection site discomfort, allergic reactions, systemic side effects affecting organs due to its broad action on cancer cell signaling pathways.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My brain cancer has returned for the first or second time.
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My high blood pressure is under control with stable medication.
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I am mostly able to care for myself but may not be able to do active work.
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I can store medicine in a fridge, give daily shots, and keep a treatment diary.
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I have completed and recovered from standard treatments for glioblastoma, including surgery and radiotherapy.
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My recent tests show my organs and bone marrow are working well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Dose Limiting Toxicities [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Establishment of Recommended Phase 2 Dose
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (fb-PMT)Experimental Treatment1 Intervention
Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.
Find a Location
Who is running the clinical trial?
NanoPharmaceuticals LLCLead Sponsor
Nicholas Blondin, MDPrincipal InvestigatorYale University
Anthony Omuro, MDPrincipal InvestigatorYale University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a stable or decreasing dose of steroids.I haven't had a stroke, heart attack, severe heart issues, or major blood vessel problems in the last 6 months.My brain cancer has returned for the first or second time.I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.My high blood pressure is under control with stable medication.I have been cancer-free and off treatment for any other cancer than non-melanoma skin cancer or cervical carcinoma in-situ for at least 3 months.I do not have any serious infections or illnesses right now.I have a serious or non-healing wound, ulcer, or bone fracture.I am mostly able to care for myself but may not be able to do active work.I can store medicine in a fridge, give daily shots, and keep a treatment diary.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.My cancer has worsened after specific targeted radiation treatments.I am not taking any medications that affect my heart's rhythm.I have completed and recovered from standard treatments for glioblastoma, including surgery and radiotherapy.I agree to use contraception and not donate sperm during and for 2 months after the study.My recent tests show my organs and bone marrow are working well.I haven't used bevacizumab or any experimental drugs in the last 28 days.I have a history of or risk factors for a specific heart rhythm problem.I haven't taken drugs that affect liver transport proteins in the last 14 days or longer.I have previously been treated with fb-PMT or similar drugs.I have a condition that increases my risk of blood clots.I had surgery within the last 28 days and the wound has not fully healed.I haven't had major heart problems like heart failure or a heart attack in the last 6 months.My heart condition is not severe.I do not have a bleeding disorder or a history of bleeding problems in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (fb-PMT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Food and Drug Administration sanctioned fb-PMT for medicinal use?
"Our team at Power assigned fb-PMT a score of 1 as its safety and efficacy has only been tested in limited capacities, thus making it a Phase 1 trial."
Answered by AI
Are there any open enrolments for this experiment?
"Affirmative. The records hosted on clinicaltrials.gov verify that this medical study, initially posted on June 23rd 2022, is in search of recruits. 28 individuals need to be recruited from one particular trial centre."
Answered by AI
How many individuals are eligible to participate in this experiment?
"Affirmative, the study is recruiting for 28 participants across a single site. Clinicaltrials.gov documents that this trial was initially posted on June 23rd 2022 and most recently revised on August 17th 2022."
Answered by AI
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