In three combined drugs used in nasopharyngeal carcinoma, the valproic acid and valganciclovir administration will be followed by indication to find the maximum tolerance dose of gemcitabine.

Nasopharyngeal Carcinoma

Gemcitabine will be administrated 600~1250 mg/m^2 intravenously according to the body surface area at day 1 and day 8 in a 28 day-treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times. The first dose level of gemcitabine will be started at 800 mg/m^2. If no subject suffered the dose limit toxicity, 1000 mg/m^2 and even 1250 mg/m^2 will be started by order. If subjects suffered the dose limit toxicity in 800 mg/m^2, the 600 mg/m^2 will be started.

Gemcitabine

Valproic acid will be administrated orally by the fixed dose 12.5 mg/kg/day according to instructions from day 1 to day 14 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valproic acid

Valganciclovir will be administrated orally by the fixed dose 1350 mg/day (creatinine clearance rate ≥ 60 mL/min) or 900 mg/day (creatinine clearance rate ≥ 40 mL/min and < 60 mL/min) from day 9 to day 15 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.

Valganciclovir

Chang-Gung Memorial Hospital, Linkou

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase I Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

According to Worst Toxicity CTCAE v4.03 Grade and FDA indication of gemcitabine, the dose limiting toxicity (DLT) of this trial was determined in the first treatment cycle and DLTs were defined as ≥1 of the following effects attributable to the study drug and requiring discontinuation or a significant dose reduction in the study drug(s):
≥Grade 4 neutropenia >5 days;
≥Grade 4 thrombopenia lasting ≥7 days;
≥Grade 3 anemia;
≥Grade 3 neutropenic fever with a single temperature of >38.3 degree C or a sustained temperature of ≥ 38 degree C for more than one hour;
any ≥Grade 3 non-hematologic toxicity with exception of nausea and vomiting, alopecia, drug-related fever;
≥Grade 3 serum creatinine;
bone marrow and renal function didn't recover to CTCAE Grade ≤ 1 of baseline at the Day 1 of the 2nd treatment course, the treatment can be postponed less than 2 weeks. DLT was recognized when the delayed duration was more than 2 weeks.

The plasma EB virus DNA load will be check by real-time quantitative polymerase chain reaction (PCR). These data will be collected every months when subjects enter this trial and finish their final treatment cycle one weeks, 3 months, and/or 6 months later. These data will be used to supplementary data for tumor status assessment.

Chang Gung Memorial Hospital

TTY Biopharm

PEGPH20: 3ug/kg on Days 1 and 4
1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15

1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15

PEGPH20: 3ug/kg on Days 1 and 4
1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15
PEGPH20
Gemcitabine
Nab-paclitaxel

Combination Therapy With 1 Week Run-In

1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15
PEGPH20
Gemcitabine
Nab-paclitaxel

Combination Therapy Alone

Total

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Our study will be investigating only clinically relevant pancreatic fistulas, i.e. grades B or C. Descriptive statistics will be used report the incidence of pancreatic fistula within the 7-day post-operative period after neoadjuvant treatment

1 cycle = 28 days
PEGPH20: 3ug/kg on Days 1, 8, 15
Gemcitabine: 1000mg/m^2 on Days 1, 8, 15
Nab-paclitaxel: 125mg/m^2 on Days 1, 8, 15
PEGPH20

Incidence of Clinically Relevant Pancreatic Fistula

Descriptive statistics with frequency / proportion will be used to evaluate rate of pathologic complete response using the pathological exam of resected tumors. pCR was defined as area of scarring in pancreatic parenchyma and/or peripancreatic soft tissue with chronic inflammation, with or without acellular mucin pools and histiocytic infiltrates, but no residual viable invasive adenocarcinoma cells in the pancreatectomy specimen

Rate of Pathologic Complete Response (pCR)

To evaluate the disease response to treatment, CA19-9 levels will be measured every 4 weeks and restaging Computerized tomography (CT) / magnetic resonance imaging (MRI)of the chest, abdomen and pelvis will be obtained every 8 weeks

Percent Change of CA19-9 Response Rate

Patients will be evaluated for surgical resection depending on imaging obtained on Cycle 4 Day 21. R0 Resection rate determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks surgical resection if the patient's tumor is deemed resectable post-therapy. Patients who have received at least 2 complete, 28-day cycles of study drugs were included in the secondary analyses

Margin-Negative (R0) Resection Rate

Descriptive statistics with frequency and proportion of overall response determined by CA 19-9 levels will be checked every 4 weeks and restaging CT/MRI of the chest, abdomen and pelvis will be obtained every 8 weeks

Overall Response Rate (ORR)

Kaplan-Meier methods will be used to analyze disease free survival and median time and 95% confidence intervals will be reported

Disease Free Survival (DFS)

Overall Study

Dr. Andrew Ko

Adenocarcinoma

PEGPH20

Nab-paclitaxel

University of California, San Francisco

PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

Perioperative Stromal Depletion Strategies in Pancreatic Ductal Adenocarcinoma

Andrew Ko

Professor of Clinical Medicine

oral ITF2357 50 mg b.i.d.
matching placebo Two parallel groups (1:1)

oral ITF2357 50 mg b.i.d.
matching placebo Two parallel groups (1:1).

Crohn's Disease

ITF2357 will be supplied as hard gelatin capsules for oral administration at the dose strength of 50 mg.

ITF2357

Placebo will be supplied as matching capsules for oral administration with the same outer appearance

Placebo capsules

University Hospital Gasthuisber

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

histone/horečka

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease

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