Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Launched by NANOPHARMACEUTICALS LLC · Jan 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called fb-PMT for patients with recurrent glioblastoma, which is a very aggressive type of brain cancer. The goal of the trial is to determine the safest dose of fb-PMT that can be used in future studies. fb-PMT is designed to affect various cancer cell pathways and can cross the blood-brain barrier, making it potentially effective for this challenging condition. The trial is currently recruiting participants aged 65-74, who have had either their first or second recurrence of glioblastoma and have completed standard treatments like surgery and radiation.

To participate, candidates must be in reasonably good health, meaning they should have a life expectancy of more than three months and be able to manage their medications, including storing and administering fb-PMT through daily injections. Participants will need to keep track of their treatment in a diary. Women must agree to regular pregnancy tests and use contraception, while men must also use contraception during the study. Overall, this trial is an important step in exploring new treatment options for patients fighting glioblastoma, and participation could contribute to advancing cancer care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically proven intracranial glioblastoma, with first or second recurrence
• • On stable or decreasing dose of steroids, if taken prior to screening
• • Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT
• • Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery/biopsy and radiotherapy
• • Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery
• • Life expectancy of more than three months
• • Karnofsky Performance Status of ≥ 70
• • Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication
• • Adequate bone marrow and organ function, confirmed by laboratory testing at screening
• • Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary
• • Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug
• • Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug
• Exclusion Criteria:
• • Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation
• • History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug
• • Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment
• • Prior therapy with fb-PMT or related drugs
• • Currently pregnant or breastfeeding
• • Active infection or serious intercurrent medical illness
• • Surgery of any type within the preceding 28 days that has not fully healed
• • A serious or non-healing wound, ulcer, or bone fracture
• • A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment
• • A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.
• • Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
• • Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
• • New York Heart Association classification of heart disease greater than Class 2
• • QTc interval \> 450 msec in males or \> 470 msec in females at screening
• • Use of concomitant medications that prolong the QT/QTc interval or risk inducing Torsades de Pointes
• • Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment
• • Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment
• • A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment
• • History of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months
• • History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)