A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
NCT ID: NCT02013050
Last Updated: 2017-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2013-12-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Control
Placebo
SGX942
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
SGX942
Interventions
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SGX942
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Soligenix
INDUSTRY
Responsible Party
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Locations
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Markey Cancer Center-University of Kentucky
Lexington, Kentucky, United States
Countries
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Other Identifiers
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IDR-OM-01
Identifier Type: -
Identifier Source: org_study_id
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