Clinical Trial Search

Primary: Number of Participants With Changes in Putative Tumor Initiating Cell Populations as Defined by Cell Surface CD44 and Intracellular Phospho-ERK1/2 Staining After…

Primary: Pathologic Response. — 25; 2; 4; 4 Participants

Primary: Toxicities Associated With Combined Radiotherapy and Erlotinib Treatments. — 15; 14; 12; 13 number of adverse events

Primary: Mean Number of Squamous Cell Carcinomas — 0.75; 1.00 # of squamous cell carcinomas — p=0.750

Primary: Early Progression Rate — 31.8 percentage of participants

Primary: Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment — 2.36; 2.83; 1.9; 2.58 unit on histologic grade scale — p=0.048

Primary: Complete Response — 81 Participants

Primary: Response (CR or PR), Stable Disease (SD), and Progressive Disease (PD) Rates — 6.81; 18.18; 75.00 percentage of participants

Primary: Percentage of Patients Free of Grade 3+ Late Toxicity — 86 percentage of participants

Primary: Duration (in Days) of Radiation Induced Severe Oral Mucositis (OM) Per World Health Organization (WHO) Criteria — 8; 1.5; 19 days

Primary: Recession Height — 1.0; 0.9 mm

Primary: Disease Specific Survival (DSS) — 29; 15; 15 participants

Primary: Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site. — 95.3 percentage of participants — p=<0.0001

Primary: Determine an Efficacious Dose (mg/cm2) of PRV111 (Cisplatin Transmucosal System) Via Number of Tumor Responses — 7 Participants

Primary: Objective Response Rate (ORR) — 4; 1; 1 Participants

Primary: Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease) — 14; 4; 19 participants

Primary: Number of Subjects With Dose Limiting Toxicities — 0 Participants

Primary: The Number of Patients With a Score of 21 or Greater by the Visual Assessment Weighted Score (VAWS). — 34 Participants

Primary: Maximum Tolerated Dose — 8 J/cm2

Primary: Complete Pathologic Response Rate — 6 Participants

Primary: Percentage of Defect Coverage — 15; 14 Gingival recessions

Primary: Number of Participants Achieving Best Overall Response — 7; 3; 1 Participants

Primary: Incidence of Treatment Emergent AE's — 36; 12; 33; 35 Participants

Primary: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. — 0.6; 0.15 units on a scale

Primary: Change in Absent in Melanoma 2 (AIM2) mRNA Expression Levels — 0.37; 0.65 fold change — p=0.3

Primary: Metabolite Associated With Inflammation (Cadaverine) — 1.119186; 0.92077 ion count — p=<0.05

Primary: Number of Participants With Adverse Events — 10; 4; 1; 20 Participants

Primary: Incidence of SCC — 3.1; 0.4 percentage of subjects

Primary: Number of Participants With 50% Reduction in Tumor Cell Count and Major Pathologic Response — 9; 6 Participants

Primary: Tumor Shrinkage — 2; 9; 36 Participants