Trial of BMX-001 or Placebo in Head and Neck Cancer Patients

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck squamous cell carcinoma Read More

Inclusion Criteria:

1. Pathologically confirmed (histologically or cytologically) diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharyngeal, or oral cavity with clinical or pathologic high-risk features who will be receiving radiation and concurrent cisplatin chemotherapy.
2. Treatment plan to receive a continuous course of IMRT delivered as single daily fractions of 2.0 to 2.1 Gy with a cumulative radiation dose between 60 Gy and 70 Gy depending on whether patients are receiving post-operative or definitive intent therapy respectively.
3. For patients undergoing curative intent resection, Patients must have undergone gross total surgical resection within 56 days prior to registration and beginning of therapy under the clinical trial.
4. General history and physical examination by a qualified head and neck cancer specialist and physician within 8 weeks prior to enrollment (including fiberoptic endoscopy).
5. Axial imaging of the neck and chest- CT, MRI and/or PET/CT is acceptable, within 8 weeks prior to date of consent.
6. Age ≥ 18 years.
7. Zubrod Performance Status 0-2 within 4 weeks prior to enrollment.
8. CBC/differential obtained within 2 weeks prior to starting the study drug with adequate bone marrow function
9. Adequate hepatic function
10. Adequate renal function defined as follows:
11. Patient must be willing and able to follow study procedures and instructions.
12. Patient must provide study-specific informed consent within 28 days prior to starting the study drug.
13. Negative pregnancy test for women of child-bearing potential within 48 hours prior to first dose of BMX-001.
14. Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment.

Exclusion Criteria:

1. Distant metastasis
2. Hypertension
3. Grade ≥2 hypotension at screening
4. Concurrent treatment with nitrates or other drugs that may, in the judgment of the treating investigator, create a risk for a precipitous decrease in blood pressure
5. History of syncope within the last 6 months
6. Patients receiving, or unable to stop use of prohibited medications
7. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
8. Women who are breast feeding are not eligible
9. Known hypersensitivity to compounds of similar chemical composition to BMX-001
10. Grade 3-4 electrolyte abnormalities (CTCAE v 5.0)
11. Prior unrelated malignancy requiring current active treatment with exceptions
12. Prior history of HNSCC receiving radiation or chemo-radiation.
13. Prior systemic chemotherapy for the study cancer (including neoadjuvant chemotherapy); note that prior chemotherapy for a different cancer is allowable.
14. Prior radiotherapy that would result in overlap of radiation treatment fields with planned treatment for study cancer.
15. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) using the specific/usual choice by clinical center for correction factor.
16. A history of additional risk factors for TdP
17. Severe, active co-morbidity as defined in the protocol