Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Last updated: January 25, 2024
Sponsor: NanoPharmaceuticals LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Neurofibromatosis

Brain Cancer

Brain Tumor

Treatment

fb-PMT

Clinical Study ID

NCT05226494
NP-100-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 glioblastomamanagement with surgery/biopsy and radiotherapy
  • Confirmation of true progressive disease for patients previously treated withinterstitial 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, prepareand administer daily subcutaneous injections on a set schedule, and record informationin a daily treatment diary
  • Women of childbearing potential must agree to ongoing pregnancy testing and to usemedically acceptable contraception for the duration of the study and for 2 monthsafter their last dose of study drug
  • Males must agree to use medically acceptable contraception and refrain from donatingsperm for the duration of the study and for 2 months after their last dose of studydrug

Exclusion

Exclusion Criteria:

  • Significant medical illness that is uncontrolled, may obscure toxicity, maydangerously alter drug metabolism, or may compromise ability for study participation
  • History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ ofthe cervix), unless in complete remission and off all therapy for that disease for atleast 3 months prior to first dose of study drug
  • Use of bevacizumab or any other experimental drug or therapy within 28 days of studytreatment
  • 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 IIIdeficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia orantiphospholipid antibody syndrome). Testing is not required in patients withoutthrombophilic history.
  • Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14days prior to study enrollment
  • Clinically significant cardiovascular event such as uncontrolled or symptomaticarrhythmias, congestive heart failure, or myocardial infarction within 6 months ofscreening.
  • 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 inducingTorsades de Pointes
  • Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or fivehalf-lives (whichever is longer) before starting study drug treatment
  • Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6months prior to study enrollment
  • A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deepvenous or arterial thrombosis) within the last 6 months prior to study enrollment
  • History of stroke, myocardial infarction, transient ischemic attack (TIA), severe orunstable angina, peripheral vascular disease, or grade II or greater congestive heartfailure within the past 6 months
  • History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heartfailure, hypokalemia, family history of Long QT Syndrome)

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: fb-PMT
Phase: 1
Study Start date:
June 23, 2022
Estimated Completion Date:
October 01, 2025

Connect with a study center

  • Smilow Cancer Hospital

    New Haven, Connecticut 06511
    United States

    Active - Recruiting

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