Overview

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Status:
Not yet recruiting
Trial end date:
2024-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
NanoPharmaceuticals LLC
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 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)