Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • A Randomized, Masked, Placebo Controlled, Phase II Trial of Concurrent Chemoradiation With BMX-001 In Patients with Head and Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation

    Cancer Categories
    • Head and Neck
    Karmanos Trial ID
    • NRG-CC013
    NCT ID
    • NCT06532279
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator

    Objective:

    Primary Objectives:

    • To compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo, defined as ≥ Grade 3 per WHO criteria from the start of radiation through 4 weeks after completion of study treatment, with additional assessments at 6, 8 and 12 weeks after completion of study treatment.

    Secondary Objectives:

    • To compare the duration of SOM in the BMX-001 arm vs. placebo arm.
    • To assess the difference between arms in the OMWQ-HN change score from baseline to 4 weeks after the end of chemoradiation.
    • To describe the incidence and severity of xerostomia and radiation dermatitis, as measured by CTCAE v5.0, in both arms.
    • To compare the duration of radiation dermatitis in the BMX-001 arm vs. placebo arm.
    • To describe toxicity, as measured by CTCAE v5.0 and PRO-CTCAE, in both arms.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions

    Karmanos Cancer Institute at McLaren Bay Region

    3140 W Campus Dr.
    Bay City, MI 48706
    Get Directions
    Phone: 989-667-2370

    Karmanos Cancer Institute at McLaren Central Michigan, Morey Cancer Center

    1221 South Drive
    Mount Pleasant, MI 48858
    Get Directions
    Phone: 989-772-6811

    Karmanos Cancer Institute at McLaren Clarkston

    5680 Bow Pointe Dr
    Clarkston, MI 48346
    Get Directions
    Phone: 248-922-6650

    Karmanos Cancer Institute at McLaren Flint

    4100 Beecher Rd
    Flint, MI 48532
    Get Directions
    Phone: 810-342-3800

    Karmanos Cancer Institute at McLaren Greater Lansing - Medical Oncology and Hematology

    3520 Forest Rd.
    Lansing, MI 48910
    Get Directions
    Phone: 517-975-9500

    Karmanos Cancer Institute at McLaren Lapeer Region

    1295 Barry Drive
    Lapeer, MI 48446
    Get Directions

    Karmanos Cancer Institute at McLaren Macomb

    1080 Harrington Blvd
    Mount Clemens, MI 48043
    Get Directions
    Phone: 586-493-7510

    Karmanos Cancer Institute at McLaren Northern Michigan, Petoskey

    560 W Mitchell St
    Petoskey, MI 49770
    Get Directions
    Phone: 231-487-3390

    Karmanos Cancer Institute at McLaren Port Huron

    1221 Pine Grove Ave
    Port Huron, MI 48060
    Get Directions
    Phone: 810-982-5200

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
    Get Directions