Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532279
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Testing the Addition of the Drug BMX-001 a Radioprotector or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral mucositis in patients who are receiving chemoradiation for head and neck cancer Oral mucositis inflammation and mouth sores is a common side effect of chemoradiation that can cause pain and difficulty swallowing Usual management of these side effects typically consists of using mouth rinses and pain medications during treatment and for several weeks after completion of treatment BMX-001 neutralizes harmful substances in the body preventing damage to macromolecules such as DNA and minimizes free radical-related toxicity in normal tissues Adding BMX-001 to usual symptom management may be more effective than usual symptom management alone at reducing oral mucositis in patients receiving chemoradiation for head and neck cancer
Detailed Description:
PRIMARY OBJECTIVE
I To compare the incidence of severe oral mucositis SOM between manganese superoxide dismutase MnSOD mimetic BMX-001 BMX-001 and placebo defined as grade 3 per World Health Organization 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
I To determine if the duration of SOM is shorter in the BMX-001 arm versus vs placebo arm
II To assess the difference in Oral Mucositis Weekly Questionnaire-Head and Neck OMWQ-HN change score from baseline to 4 weeks after the end of radiation
III Incidence and severity of xerostomia and radiation dermatitis as measured by Common Terminology Criteria for Adverse Events CTCAE version v50
IV To determine if the duration of radiation dermatitis is shorter in the BMX-001 arm vs placebo arm
V Toxicity as measured by CTCAE v50 and Patient Reported Outcome PRO-CTCAE
EXPLORATORY OBJECTIVES
I To assess the between arm difference in progression-free survival PFS II To assess the between arm difference in overall survival OS III Data demonstrating improvement in pain as measured by reduction in narcotic use between BMX-001 versus usual care
IV Collect serum plasma and imaging studies for future translational research analyses
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients receive weekly cisplatin and undergo image-guided intensity-modulated radiation therapy per standard of care SOC In addition to usual symptom management patients receive placebo subcutaneously SC as early as 4 days and no later than one hour prior to their first dose of radiation therapy Patients then receive placebo SC twice a week BIW for 8 weeks 16 doses Patients also undergo computed tomography CT andor magnetic resonance imaging MRI on study and may optionally undergo collection of blood serum andor plasma throughout the study
ARM 2 Patients receive weekly cisplatin and undergo image-guided intensity-modulated radiation therapy per SOC In addition to usual symptom management patients receive BMX-001 SC as early as 4 days and no later than one hour prior to their first dose of radiation therapy Patients then receive BMX-001 SC BIW for 8 weeks 16 doses Patients also undergo CT andor MRI on study and may optionally undergo collection of blood serum andor plasma throughout the study
After completion of study treatment patients are followed up at 1 2 3 6 12 and 24 months
I To compare the incidence of severe oral mucositis SOM between manganese superoxide dismutase MnSOD mimetic BMX-001 BMX-001 and placebo defined as grade 3 per World Health Organization 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
I To determine if the duration of SOM is shorter in the BMX-001 arm versus vs placebo arm
II To assess the difference in Oral Mucositis Weekly Questionnaire-Head and Neck OMWQ-HN change score from baseline to 4 weeks after the end of radiation
III Incidence and severity of xerostomia and radiation dermatitis as measured by Common Terminology Criteria for Adverse Events CTCAE version v50
IV To determine if the duration of radiation dermatitis is shorter in the BMX-001 arm vs placebo arm
V Toxicity as measured by CTCAE v50 and Patient Reported Outcome PRO-CTCAE
EXPLORATORY OBJECTIVES
I To assess the between arm difference in progression-free survival PFS II To assess the between arm difference in overall survival OS III Data demonstrating improvement in pain as measured by reduction in narcotic use between BMX-001 versus usual care
IV Collect serum plasma and imaging studies for future translational research analyses
OUTLINE Patients are randomized to 1 of 2 arms
ARM 1 Patients receive weekly cisplatin and undergo image-guided intensity-modulated radiation therapy per standard of care SOC In addition to usual symptom management patients receive placebo subcutaneously SC as early as 4 days and no later than one hour prior to their first dose of radiation therapy Patients then receive placebo SC twice a week BIW for 8 weeks 16 doses Patients also undergo computed tomography CT andor magnetic resonance imaging MRI on study and may optionally undergo collection of blood serum andor plasma throughout the study
ARM 2 Patients receive weekly cisplatin and undergo image-guided intensity-modulated radiation therapy per SOC In addition to usual symptom management patients receive BMX-001 SC as early as 4 days and no later than one hour prior to their first dose of radiation therapy Patients then receive BMX-001 SC BIW for 8 weeks 16 doses Patients also undergo CT andor MRI on study and may optionally undergo collection of blood serum andor plasma throughout the study
After completion of study treatment patients are followed up at 1 2 3 6 12 and 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None