A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
This trial is active, not recruiting.
|Start date||December 2013|
|End date||December 2015|
|Trial size||78 participants|
|Trial identifier||NCT02013050, IDR-OM-01|
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Lexington, KY||University of Kentucky / Markey Cancer Center||no longer recruiting|
|Ann Arbor, MI||University of Michigan Comprehensive Cancer Center||no longer recruiting|
|Detroit, MI||Wayne State University / Karmanos Cancer Institute||no longer recruiting|
|Saint Louis, MO||Siteman Cancer Center at Washington University||no longer recruiting|
|Bronx, NY||Montefiore Medical Center-Weiler Hospital||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Health Sciences||no longer recruiting|
|Cleveland, OH||Case Comprehensive Cancer Center||no longer recruiting|
|Columbus, OH||Ohio State University Comprehensive Cancer Center||no longer recruiting|
|Seattle, WA||Fred Hutch / University of Washington Cancer Consortium||no longer recruiting|
|Madison, WI||University of Wisconsin Hospital and Clinics||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
Oral Mucositis Symptoms
time frame: 4 weeks after end of therapy
Male or female participants at least 18 years old.
Inclusion Criteria: - Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT. - Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation. - Planned to receive standard cisplatin chemotherapy administered either weekly or every third week. - Must be able to read and understand informed consent - Adequate birth control methods for the duration of the study Exclusion Criteria: - Current mucositis. - Prior radiation to the head and neck. - Chemotherapy treatment within the previous 12 months. - Tumors of the lips, sinuses, salivary glands or nasopharynx. - Unknown primary tumor. - Stage 4c metastases. - Evidence of significant hepatic, hematologic, or immunologic disease. - Women who are pregnant or breast-feeding.
|Official title||A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck|
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