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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|