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NCT05226494 | RECRUITING | Glioma, Malignant

Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma
Sponsor:

NanoPharmaceuticals LLC

Brief 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.

Condition or disease

Glioma, Malignant

Intervention/treatment

fb-PMT

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 34 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma
Actual Study Start Date : 2022-06-23
Estimated Primary Completion Date : 2024-10-01
Estimated Study Completion Date : 2025-10-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma

Location Details

NCT05226494

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Locations

RECRUITING

United States, Connecticut

Smilow Cancer Hospital

New Haven, Connecticut, United States, 06511