A Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer (BMX-HN)
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|ClinicalTrials.gov Identifier: NCT02990468|
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : August 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: BMX-001 Radiation: Radiation Therapy Drug: Cisplatin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a-b Trial of Concurrent Radiation Therapy, Cisplatin, and BMX-001 in Locally Advanced Head and Neck Cancer|
|Actual Study Start Date :||April 19, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Radiation Therapy, Cisplatin and BMX-001
In Phase 1a, safety and tolerability of BMX-001 will be assessed using a Continual Reassessment Method and a maximum tolerated dose (MTD) will be determined using a single arm design. In Phase 1b, the severity of radiation-induced mucositis and xerostomia will be assessed using a single arm design.
Subcutaneous injection.Radiation: Radiation Therapy
Patients will receive standard dose intensity modulated radiation therapy (IMRT).Drug: Cisplatin
Cisplatin will be administered per institution's standard of care practice.
- Maximum Tolerated Dose (MTD) of BMX-001 in combination with standard radiation therapy and cisplatin, defined as the dose level that has an estimated dose limited toxicity (DLT) rate nearest to 0.25. [ Time Frame: 1 year ]
- Reduction of radiation-induced mucositis [ Time Frame: 1 year ]Mucositis will be scored using the CTCAE version 4.03 and evaluation will also be done using the Functional Assessment of Cancer Therapy for Head and Neck (FACT-HN) to be administered on screening and post therapy.
- Reduction of radiation-induced mucositis [ Time Frame: 1 year ]Mucositis will be scored using the CTCAE version 4.03 and evaluation will also be done using the Oral Mucositis Weekly Questionaire-Head+Neck (OMWQ-HN) to be administered on screening and post therapy.
- Reduction of radiation-induced xerostomia [ Time Frame: 1 year ]Xerostomia will be assessed using the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN).
- Reduction of radiation-induced xerostomia [ Time Frame: 1 year ]Xerostomia will be assessed using the Xerostomia-Related Quality of Life Scale (XeQoLS).
- Reduction of radiation-induced xerostomia [ Time Frame: 1 year ]Xerostomia will also be assessed by measurement of both unstimulated and stimulated saliva production at baseline, at the end of radiation therapy, and at 6 and 12 months post radiation therapy.
- Progression-free survival [ Time Frame: 1 year ]
- Peak plasma concentrations (Cmax) for BMX-001 [ Time Frame: 1 year ]
- Area under the plasma concentration versus time curve (AUC) for BMX-001 [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990468
|Contact: Sara Penchevemail@example.com|
|Contact: James D Crapo, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Joan Cahill, RN 919-668-5211 email@example.com|