Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    28
  • sponsor
    NanoPharmaceuticals LLC
Updated on 4 October 2022
cancer
karnofsky performance status
brain tumor
recurrent glioblastoma

Summary

Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.

Details
Condition Glioma, Malignant
Treatment fb-PMT
Clinical Study IdentifierNCT05226494
SponsorNanoPharmaceuticals LLC
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 Cytochrome P450 (CYP) inhibitors or CYP inducers 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)
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