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
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 StatesActive - Recruiting
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